{"id":137354,"date":"2026-03-30T10:14:32","date_gmt":"2026-03-30T10:14:32","guid":{"rendered":"https:\/\/my.legal500.com\/guides\/?post_type=comparative_guide&#038;p=137354"},"modified":"2026-03-30T10:14:32","modified_gmt":"2026-03-30T10:14:32","slug":"united-states-life-sciences","status":"publish","type":"comparative_guide","link":"https:\/\/my.legal500.com\/guides\/chapter\/united-states-life-sciences\/","title":{"rendered":"United States: Life Sciences"},"content":{"rendered":"","protected":false},"template":"","class_list":["post-137354","comparative_guide","type-comparative_guide","status-publish","hentry","guides-life-sciences","jurisdictions-united-states"],"acf":[],"appp":{"post_list":{"below_title":"<div class=\"guide-author-details\"><span class=\"guide-author\">Barnes &amp; Thornburg LLP<\/span><span class=\"guide-author-logo\"><img src=\"https:\/\/my.legal500.com\/guides\/wp-content\/uploads\/sites\/1\/2024\/03\/BT_Color_Stacked_BlkText_072517.jpg\"\/><\/span><\/div>"},"post_detail":{"above_title":"<div class=\"guide-author-details\"><span class=\"guide-author\">Barnes &amp; Thornburg LLP<\/span><span class=\"guide-author-logo\"><img src=\"https:\/\/my.legal500.com\/guides\/wp-content\/uploads\/sites\/1\/2024\/03\/BT_Color_Stacked_BlkText_072517.jpg\"\/><\/span><\/div>","below_title":"<span class=\"guide-intro\">This country specific Q&amp;A provides an overview of Life Sciences laws and regulations applicable in United States<\/span><div class=\"guide-content\"><div class=\"filter\">\r\n\r\n\t\t\t\t<input type=\"text\" placeholder=\"Search questions and answers...\" class=\"filter-container__search-field\">\r\n\t\t\t<\/div>\r\n\r\n\t\t\t\r\n\r\n\r\n\t\t\t<ol class=\"custom-counter\">\r\n\r\n\t\t\t\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Please briefly summarize your country's legislative framework for medicinal products (including biologicals), medical devices, food, and food supplements<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>The Food and Drug Administration (\u201cFDA\u201d) maintains authority over labeling for food, pharmaceutical products, medical devices, and cosmetics, and over advertising for prescription medications and certain categories of medical devices pursuant to the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. \u00a7 301, <em>et seq. <\/em>(\u201cFDCA\u201d).\u00a0 FDA works with the Department of Justice (\u201cDOJ\u201d) to enforce these regulations in federal courts.\u00a0 The Federal Trade Commission (\u201cFTC\u201d) regulates advertising (other than labeling) for food, over-the-counter (\u201cOTC\u201d) products, cosmetics, and non-restricted medical devices under the Federal Trade Commission Act, which prohibits a variety of \u201cunfair or deceptive acts or practices,\u201d including the dissemination of false advertisements directed to consumers.\u00a0 <em>See <\/em>15 U.S.C. \u00a7\u00a7 45, 52, 55; 21 U.S.C. \u00a7 352(r).\u00a0 The Drug Enforcement Agency (\u201cDEA\u201d) regulates certain prescription medicines that have a potential for abuse pursuant to the Controlled Substances Act, 21 U.S.C. \u00a7 801, <em>et seq.\u00a0 <\/em>Depending on the product, state agencies may also administer certain labeling and licensing requirements.<\/p>\n<p>The pre-emption doctrine protects product manufacturers from liability based on regulatory approval.\u00a0 For prescription medicines approved by FDA, a plaintiff\u2019s claims that a manufacturer failed to warn of a particular adverse event asserted pursuant to state law are pre-empted if there is \u201cclear evidence\u201d that FDA would not have approved the warning that a plaintiff has proposed.\u00a0 <em>Wyeth v. Levine<\/em>, 555 U.S. 555 (2009).\u00a0 These claims may be pre-empted where plaintiffs cannot identify \u201cnewly acquired information\u201d that would have allowed the product manufacturer to unilaterally update the product\u2019s labeling without prior FDA approval.\u00a0 <em>Gibbons v. Bristol-Myers Squibb Co.<\/em>, 919 F.3d 699, 707\u201308 (2d Cir. 2019); <em>see also<\/em> 21 C.F.R. \u00a7 314.70; 21 C.F.R. \u00a7 314.3.\u00a0 For medical devices governed by the Medical Device Amendments of 1976 (\u201cMDA\u201d), the MDA \u201cexpressly pre-empts only state requirements \u2018different from, or in addition to, any requirement applicable . . . to the device\u2019 under federal law.\u201d <em>Riegel v. Medtronic<\/em>, 552 U.S. 312, 321 (2008).\u00a0 For OTC products, the FDCA pre-empts any state or local government requirement \u201cthat is different from or in addition to, or that is otherwise not identical with, a requirement under\u201d the FDCA, in addition to the Fair Packaging and Labeling Act, 15 U.S.C. \u00a7 1451, <em>et seq.<\/em>, or the Poison Prevention Packaging Act of 1970, 15 U.S.C. \u00a7 1471, <em>et seq.\u00a0 F<\/em>or food products, the FDCA contains an express pre-emption provision providing that states must not have food labeling requirements that are not \u201cidentical\u201d to those in the FDCA. <em>See<\/em> 21 U.S.C. \u00a7 343-1.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">With regards to medicinal products and medical devices, how is the regulatory process structured in your jurisdiction from R&amp;D through market approval until post-marketing vigilance, and what rules does it follow? Please briefly describe.<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>There are three main avenues through which to bring a medical device to market, determined by \u201cthe risk posed by a device,\u201d which \u201ccan change classification systems depending on the results of scientific data.\u201d\u00a0 <em>See <\/em>FDCA \u00a7 513; The Device Development Process, <em>available at <\/em><a href=\"https:\/\/www.fda.gov\/patients\/learn-about-drug-and-device-approvals\/device-development-process\">https:\/\/www.fda.gov\/patients\/learn-about-drug-and-device-approvals\/device-development-process<\/a>.\u00a0 Class I devices pose low risk, such as oxygen masks and handheld surgical instruments.\u00a0 Class III devices are those that \u201csupport or sustain life, are implanted in the body, or have the potential for unreasonable risk of illness or injury,\u201d such as pacemakers. <em>Id<\/em>.\u00a0 Class II devices fall in between the other two classes.\u00a0 Regardless of the classification, the product lifecycle begins with preclinical research, during which prototypes are developed and studied to assess the product\u2019s benefits and potential associated risks. <em>Id.<\/em><\/p>\n<p>To obtain FDA approval, there are different requirements based on the classification of the product. Class I and II are subject to pre-market notice \u2013 also referred to as 510(k) for the relevant code section \u2013 which requires that the manufacturer demonstrate the substantial equivalence of the new product to a legally marketed device.\u00a0 Substantial equivalence means that \u201cthat the device to be marketed is as safe, effective\u201d as an already marketed product not subject to premarket approval.<\/p>\n<p>Class III devices are subject to premarket approval (PMA), which requires a higher showing from the manufacturer. <em>See, e.g.<\/em>, <em>Buckman Co. v. Plaintiffs\u2019 Legal Comm.<\/em>, 531 U.S. 341, 344-45 (2001). The PMA application must demonstrate \u201creasonable assurance\u201d that the device is both \u201cSafe\u2026[and] effective under the conditions of use prescribed, recommended, or suggested in the proposed labeling thereof.\u201d 21 U.S.C.S. \u00a7 360e(d)(2)(A), (B).\u00a0 To do so, the application must include: (1) all known reports pertaining to the device\u2019s safety and efficacy; (2) a full statement of the components, ingredients, and properties and of the principles of operation of the device; (3) a full description of the methods used in, and the facilities and controls used for, the manufacture, processing of the device; (4) samples of the device; (5) the proposed labeling that will accompany the device. <em>See id<\/em>. at (B)-(F).\u00a0 FDA requires an average of 1,200 hours to review each PMA submission. <em>Medtronic, Inc. v. Lohr<\/em>, 518 U.S. 470, 477 (1996).<\/p>\n<p>For all devices, FDA imposes certain controls or obligations that the manufacturer must comply with in the manufacture, marketing, and sale of the device.\u00a0 Additionally, FDA conducts routine inspections of manufacturing facilities across the United States.\u00a0 Finally, device manufacturers are required to report known adverse events to FDA, who monitors these reports to assess whether any change in approval conditions is required.<\/p>\n<p>FDA promulgates the current good manufacturing practices (\u201cCGMP\u201d), which provides guidance on best practices for manufacturing of devices already on the market.\u00a0 In February 2024, FDA issued a final rule to harmonize the CGMP with the quality management system (\u201cQMS\u201d) requirements used by regulatory authorities in other countries.\u00a0 The goal of this final rule is to increase consistency between FDA regulations of devices and similar regulations in these other countries. This rule is set to take effect on February 2, 2026.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">What is the regulatory process for food supplements, from first notification to the competent authorities until post-marketing vigilance in your country, and what regulations are applicable here? Please briefly describe.<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>\u201cDietary supplements are regulated by FDA as food, not as drugs.\u201d Dietary Supplements, <em>available at <\/em><a href=\"https:\/\/www.fda.gov\/consumers\/consumer-updates\/dietary-supplements%23:~:text=Dietary%20supplements%20are%20regulated%20by,as%20food%2C%20not%20as%20drugs.\">https:\/\/www.fda.gov\/consumers\/consumer-updates\/dietary-supplements#:~:text=Dietary%20supplements%20are%20regulated%20by,as%20food%2C%20not%20as%20drugs.<\/a>\u00a0 Under the Dietary Supplement Health and Education Act (DSHEA), passed in 1994, FDA has authority to regulate dietary supplements.\u00a0 If a dietary supplement is found to be adulterated or misbranded, FDA can remove such a product from the marketplace or take other action to rectify the misbranding.<\/p>\n<p>Additionally, FTC regulated dietary supplement advertising by enforcing truth-in-advertising laws. Dietary supplements cannot be advertised as treating, preventing, or curing any disease or health condition.\u00a0 Additionally, the product label must contain a truthful listing of the dietary supplement\u2019s ingredients and a recommended serving size.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">What are the ongoing obligations in your country after a marketing authorization for medicinal products has been obtained or a conformity assessment been carried out for medical devices?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>Life sciences companies may have a duty to disclose adverse event reports to FDA through a public reporting database known as the Manufacturer and User Facility Device Experience (\u201cMAUDE\u201d), which are publicly available.<\/p>\n<p>Medical device manufacturers are required to report, \u201cwithin 30 calendar days after the day [they] receive or otherwise become aware of information, from any source, that reasonably suggests that a device\u201d caused or contributed to serious injury or death, or a device malfunction that could cause serious injury or death if it were to recur. 21 C.F.R. 803.50.\u00a0 These reports must include, <em>inter alia<\/em>, patient information (name, age, gender, weight), the nature of the adverse event, the outcome attributed to the adverse event, and all actions taken to investigate the adverse event. 21 C.F.R. 803.52.<\/p>\n<p>An importer of a medical device must report adverse events leading to death or serious injury to FDA and the device manufacturer within 30 days. 21 C.F.R. 803.40.\u00a0 Additionally, they must report device malfunctions, even those not involving death or serious injury, to the device manufacturer.<\/p>\n<p>User facilities, defined as a \u201chospital, ambulatory surgical facility, nursing home, outpatient diagnostic facility, or outpatient treatment facility\u2026which is not a physician\u2019s office,\u201d also have reporting obligations. 21 C.F.R. 803.3.\u00a0 They must report instances where the information \u201creasonably suggests that a device has or may have caused or contributed to\u201d death or serious injury. 21 C.F.R. 803.30.\u00a0 These reports must be made to FDA, the manufacturer, or both, within 10 days of the user facility becoming aware of the information.<\/p>\n<p>FDA recently announced that it will be transitioning its adverse event reporting databases. <em>See<\/em> FDA Launches New Adverse Event Look-Up Tool, <em>available at <\/em><a href=\"https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-launches-new-adverse-event-look-tool\">https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-launches-new-adverse-event-look-tool<\/a>. The new system is aimed at addressing the \u201cfragmented\u201d prior system, under which reports were housed on different systems based on the type of product. The new system will centralize reports into one database.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Which are the competent national authorities having the regulatory oversight over medicinal products, medical devices, food, and food supplements and what are their respective responsibilities?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>FDA has broad authority to regulate pharmaceuticals, medical devices, and food. This authority relates to the design and manufacturing of these products.\u00a0 It also covers promotion and marketing that is not direct to consumer.<\/p>\n<p>FTC has authority to regulate direct to consumer advertising.\u00a0 FTC is tasked with regulating and enforcing requirements that prohibit unfair or deceptive acts or practices in or affecting commerce as well as false advertisement. <em>See <\/em>Response to Question 1 for a more thorough description.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Please briefly describe the procedure of challenging regulatory decisions (e.g., denial of marketing authorization) made by the competent regulatory authority in relation to medicinal products, medical devices, and food supplements.<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>Since FDA is a federal agency, the principles of administrative law and the Administrative Procedure Act govern challenges to regulatory decisions.\u00a0 For medical devices, there is a requirement that the agency action be a \u201csignificant decision\u201d to be entitled to an FDA supervisory appeal. 21 C.F.R. 800.75.\u00a0 Such actions include decision on 510(k) substantial equivalent, PMA approvals, Breakthrough Device Designation Requests, and IDE.<\/p>\n<p>Upon exhaustion of agency appeals, one can file a lawsuit in court to challenge the agency\u2019s actions.\u00a0 Those adversely affected or aggrieved by agency action within the meaning of a relevant statute or those who experience a legal wrong because of agency action, have standing to challenge the agency action in court.\u00a0 Courts will apply the arbitrary and capricious standard.<\/p>\n<p>This standard \u201crequires that agency action be reasonable and reasonably explained. Judicial review under this standard is deferential, and a court may not substitute its own policy judgment for that of the agency.\u201d <em>FCC v. Prometheus Radio Project<\/em>, 141 S. Ct. 1150, 1158 (2021).\u00a0 Therefore, courts will uphold agency actions unless it is demonstrated that the agency acted unreasonably or has failed to satisfactorily explain the basis for its decision.<\/p>\n<p>In June 2024, the Supreme Court issued a ruling that may curtail agency authority. <em>Loper Bright Enterprises, et al. v. Raimondo<\/em>, 603 US 369 (2024).\u00a0 However, this decision applies to a court\u2019s review of any ambiguity in a Congressional act delegating power to a federal agency.\u00a0 Agencies are still granted deference when they are acting within the scope of the delegated authority or where the enabling act is not ambiguous. \u00a0Since the <em>Loper Bright<\/em> decision, there have been lawsuits related to FDA regulation. <em>See, e.g.<\/em>, <em>Am. Clinical Lab\u2019y Ass\u2019n v. U.S. Food &amp; Drug Admin.<\/em>, 776 F. Supp. 3d 554, 559 (E.D. Tex. 2025); <em>Eli Lilly and Company v. Kennedy, et al.<\/em>, 1:24-cv-1503 (S.D. Ind. 2024).<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Please briefly describe the legal framework and the relevant regulatory procedure (e.g., application process, requirements, approval, denial) that applies in your jurisdiction to clinical trials for medicinal products and medical devices.<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>FDA provides regulatory guidance over clinical trials and compassionate use programs. <em>See<\/em> 21 C.F.R. \u00a7 50, FDA, <em>Regulations: Good Clinical Practice and Clinical Trials<\/em> (Aug. 28, 2019), <em>available at<\/em> https:\/\/www.fda.gov\/science-research\/clinical-trials-and-human-subject-protection\/regulations-good-clinical-practice-and-clinical-trials. All clinical trials conducted in connection with securing FDA approval to market must adhere to the requirements of 21 C.F.R. Parts 50 and 56. Part 50 addresses the need to secure informed consent from human subjects who participate in clinical trials.\u00a0 Part 56 addresses the need to secure review of clinical investigation by the Institutional Review Board (\u201cIRB\u201d), which is tasked with approving and monitoring the clinical trial process. Waiver of the IRB review requirement may be obtained pursuant to 21 C.F.R. 56.105 upon application by the sponsor to FDA.<\/p>\n<p>An initial new drug application (\u201cIND\u201d) may apply to one or more of the clinical phases and must detail the design of the clinical investigation and the investigators who will be conducting the trials, in addition to how the data will be gathered, maintained, and analyzed. 21 C.F.R. Part 312. An investigational device exception (\u201cIDE\u201d) is required for devices that may not be introduced in the market by filing a 510(k) or pre-market notice, but instead require a PMA. 21 C.F.R. Part 812.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Is there a public database for clinical trials in your country, and what are the rules for publication?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>The National Center for Biotechnology Information, a division of the National Institute of Health, maintains <a href=\"https:\/\/clinicaltrials.gov\/\">ClinicalTrials.gov<\/a>.\u00a0 This database covers most clinical trials in the United States and includes studies in all 50 states and over 200 countries.<\/p>\n<p>Two categories of device clinical trials must be registered.\u00a0 First, if the \u201cstudy is a pediatric postmarket surveillance of a device product.\u201d 42 C.F.R. \u00a711.22(b).\u00a0 Second, the trial must be registered if it is an interventional study with a primary purpose other than feasibility and any of the following apply: (1) at least one facility where the trial is being conducted is within the United States; (2) the device being investigated is manufactured in and exported from the United States for study in another country; or (3) the clinical trial has an investigational device exemption number. <em>Id<\/em>.<\/p>\n<p>A clinical pharmaceutical trial must be registered if it is interventional, is not a phase 1 study, is studying an FDA regulated pharmaceutical product; and any of the following apply: (1) at least one facility where the trial is being conducted is within the United States; (2) the pharmaceutical being investigated is manufactured in and exported from the United States for study in another country; or (3) the clinical trial has an IND number. <em>Id<\/em>.<\/p>\n<p>Even if not required to be listed on <a href=\"https:\/\/clinicaltrials.gov\/\">ClinicalTrials.gov<\/a>, the study sponsors can choose to have their clinical trials registered, nonetheless.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Please briefly summarize the rules that must be observed in your jurisdiction when using data from clinical trials?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>Clinical trials necessarily require the collection of Personal Health Information (\u201cPHI\u201d), which triggers certain requirements under the Health Insurance Portability and Accountability Act of 1996 (\u201cHIPAA\u201d).\u00a0 In addition to the federal requirements under HIPPA, many states have enacted laws to help protect clinical trial subjects\u2019 personal data, which impose obligations similar to those under GDPR, such as notice, data privacy rights, and security measures. Yet, there are carve-outs in certain state laws that make them inapplicable to research activities such as clinical trials.<\/p>\n<p>At the federal level, HIPAA only applies to \u201ccovered entities,\u201d which include health insurers, healthcare providers, and their business associates. Since clinical trials sponsors typically fall outside of the definition of \u201ccovered entities,\u201d i.e. pharmaceutical companies, HIPAA is not applicable, and the trial sponsors must ensure that they do not assume the obligation to comply with HIPAA by contracting with a covered entity. Given that HIPAA generally does not apply, trial sponsors often place assurances and obligations in the informed consent forms that trial participants sign.<\/p>\n<p>Also applicable is the Health Information Technology for Economic and clinical Health Act (\u201cHITECH\u201d).\u00a0 HITECH was passed in 2009 to incentivize the adoption of electronic medical records. Contained in the act were provisions permitting the enforcement of HIPAA\u2019s data privacy rules in addition to an obligation to notify patients of any date breach or unauthorized disclosure of their personal data. Companies found to be in \u201cwillful neglect\u201d of the requirements under HIPAA and HITECH can be fined up to $250,000 for a first offense and $1.5 million for each subsequent incident.<\/p>\n<p>California\u2019s data privacy law serves as a good example of how state laws exempt clinical trial data from their purview. Cali. Civil Code \u00a71798.100.\u00a0 While the law works to safeguard Californians personal data, it does not apply to \u201cinformation collected as part of a clinical trial subject to the Federal Policy for the Protection of Human subjects.\u201d <em>Id<\/em>.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Are there any trends and\/or legislative proposals in your country on digitizing the process of conducting clinical trials (e.g., digitalization of the application process, decentralization of clinical trials)?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>FDA maintains authority over labeling for food, pharmaceutical products, medical devices, and cosmetics, and over advertising for prescription medications and certain categories of medical devices pursuant to the FDCA. FDA has recognized the importance of leveraging technology to enhance the conduct of clinical trials. Section 745A(a) of the FDCA [added by section 1136 of the Food and Drug Administration Safety and Innovation Act (FDASIA) (Public Law 112-144)], requires that submissions under section 505(b), (i), or (j) of the FDCA and submissions under section 351(a) or (k) of the Public Health Service Act (PHS Act) be submitted in electronic format specified by FDA beginning no earlier than 24 months after FDA issues a final guidance specifying an electronic submission format. To comply with section 745(A)(a), regulatory documents must be submitted electronically at least 24 months after FDA issues a final guidance document.\u00a0 <em>See id.; see also<\/em> 21 C.F.R. \u00a7 11; <a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/part-11-electronic-records-electronic-signatures-scope-and-application#ret2\">https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/part-11-electronic-records-electronic-signatures-scope-and-application#ret2<\/a>.<\/p>\n<p>Informing FDA\u2019s trend towards digitization of clinical trials is the September 2013 guidance, \u201cElectronic Source Data in Clinical Investigations\u201d, which was intended to streamline and modernize clinical investigation by addressing source data in clinical investigations used to fill the predefined fields in an electronic case report form (eCRF).\u00a0 This FDA industry guidance promotes capturing source data in electronic form, and is intended to assist in ensuring the reliability, quality, integrity, and traceability of data from electronic source to electronic regulatory submission, and is <em>available at<\/em> <a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/electronic-source-data-clinical-investigations\">https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/electronic-source-data-clinical-investigations<\/a>.<\/p>\n<p>For Investigational New Drug (IND) application, FDA has implemented the Electronic Common Technical Document (eCTD) format, which provides for the electronic submission of regulatory information.\u00a0 In February 2020, FDA issued relevant guidance on eCTD, \u201cProviding Regulatory Submissions in Electronic Format \u2014 Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications Guidance for Industry\u201d, <em>available at<\/em> <a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/providing-regulatory-submissions-electronic-format-certain-human-pharmaceutical-product-applications\">https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/providing-regulatory-submissions-electronic-format-certain-human-pharmaceutical-product-applications<\/a>. The eCTD format is also commonly used for New Drug Applications (NDAs).\u00a0 In April 2024, FDA issued relevant guidelines on regulatory submissions, \u201cProviding Regulatory Submissions in Electronic Format: \u00a0IND Safety Reports\u201d, <em>available at\u00a0 <\/em><a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/providing-regulatory-submissions-electronic-format-ind-safety-reports-guidance-industry\">https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/providing-regulatory-submissions-electronic-format-ind-safety-reports-guidance-industry<\/a>.\u00a0 This document provides guidelines for the electronic format that sponsors should use when submitting IND safety reports for suspected adverse reactions.<\/p>\n<p>FDA has recognized that technological advances can now facilitate remote vs. in-person vs. hybrid participation in decentralized clinical trials (DCTs), in which some or all trial-related activities occur at locations other than traditional clinical trial sites.\u00a0 In May 2023, FDA issued a relevant guidance document of recommendations for DCTs, \u201cDecentralized Clinical Trials for Drugs, Biological Products, and Devices\u201d, <em>available at<\/em> <a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/decentralized-clinical-trials-drugs-biological-products-and-devices\">https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/decentralized-clinical-trials-drugs-biological-products-and-devices<\/a>.<\/p>\n<p>In December 2023, FDA issued additional guidance with recommendations on the use of digital health technologies (DHTs) to acquire data remotely from participants in clinical investigations that evaluate medical products, \u201cDigital Health Technologies for Remote Data Acquisition in Clinical Investigations\u201d, <em>available at<\/em> <a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/digital-health-technologies-remote-data-acquisition-clinical-investigations\">https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/digital-health-technologies-remote-data-acquisition-clinical-investigations<\/a>.\u00a0 The guidance emphasized reliability, privacy, quality, and safety as clinical trials tend to become more decentralized, flexible, accessible, and technology reliant.<\/p>\n<p>In 2025, FDA issued\/updated final guidance, which formally defines decentralized trials as those where activities occur outside traditional sites (e.g., home, local providers, telehealth). Decentralized elements are no longer exceptional.\u00a0 They are explicitly accepted and structured within regulatory expectations. The 2025 update marks the transition from experimental, COVID-era decentralized trials to a formal, FDA-endorsed hybrid model\u2014where digital tools and remote participation are expected but tightly governed for data quality and safety.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">What are your country's legal requirements for the authorization of manufacturing plants for medicinal products, medical devices, food, and food supplements? Please briefly describe.<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>There are licensing and registration requirements for facilities manufacturing medicinal products, medical devices, food, and food supplements.\u00a0 <em>See, e.g.,<\/em> 21 U.S.C. \u00a7\u00a7 350(d), 360; 21 C.F.R. \u00a7\u00a7 1(H), <em>et seq.<\/em>\u00a0 In addition, state business license requirements, which may require proof of registration of a prescription medicine with FDA, certain corporate documentation, a self-inspection report and more, may also apply depending on the state(s) involved.<\/p>\n<p>To ensure the safety, quality, and efficacy of medicinal products, FDA enforces Current Good Manufacturing Practice (CGMP) regulations for pharmaceutical manufacturing plants, including in the Current Good Manufacturing Practice in Manufacturing Processing, Packing, or Holding of Drugs, <em>available at <\/em><a href=\"https:\/\/www.fda.gov\/drugs\/pharmaceutical-quality-resources\/current-good-manufacturing-practice-cgmp-regulations\">https:\/\/www.fda.gov\/drugs\/pharmaceutical-quality-resources\/current-good-manufacturing-practice-cgmp-regulations<\/a>. For CGMP relating to food supplement, <em>see also <\/em><a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/small-entity-compliance-guide-current-good-manufacturing-practice-manufacturing-packaging-labeling#VII\">https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/small-entity-compliance-guide-current-good-manufacturing-practice-manufacturing-packaging-labeling#VII<\/a>. The CGMP\u2019s detailed requirements address various aspects of manufacturing medicinal products, including facility design, equipment, personnel, production processes, packaging and labeling control, and documentation required for certification.\u00a0 FDA provides similar guidance documents to address specific manufacturing requirements relating to medical devices and food, <em>accessible via<\/em> <a href=\"https:\/\/www.fda.gov\/inspections-compliance-enforcement-and-criminal-investigations\/compliance-manuals\/manual-compliance-policy-guides\">https:\/\/www.fda.gov\/inspections-compliance-enforcement-and-criminal-investigations\/compliance-manuals\/manual-compliance-policy-guides<\/a>.<\/p>\n<p>In December 2024, FDA released its final guidance on the \u201cAdvanced Manufacturing Technologies Designation Program\u201d, which encourages\u00a0the early adoption of advanced manufacturing technologies (AMTs) that have the potential to benefit patients by improving manufacturing and supply dependability and optimizing development time of pharmaceutical and biological products.\u00a0\u00a0 <a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/advanced-manufacturing-technologies-designation-program?utm_medium=email&amp;utm_source=govdelivery\">https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/advanced-manufacturing-technologies-designation-program<\/a>.<\/p>\n<p>The FDA launched a new program in 2025 (implemented in 2026) designed to streamline and de-risk the setup and approval of new U.S. drug manufacturing facilities, <em>available at <\/em><a href=\"https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-launches-precheck-pilot-program-strengthen-domestic-pharmaceutical-manufacturing\">FDA Launches PreCheck Pilot Program to Strengthen Domestic Pharmaceutical Manufacturing | FDA<\/a>.<\/p>\n<p>The Quality Management System Regulation (QMSR) that became effective on February 2, 2026 that aligns U.S. regulations with ISO 13485:2016 standards, <em>available at <\/em><a href=\"https:\/\/www.fda.gov\/medical-devices\/postmarket-requirements-devices\/quality-management-system-regulation-qmsr\">Quality Management System Regulation (QMSR) | FDA<\/a>.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Please briefly describe the typical process of distributing medicinal products, medical devices, and food supplements in your country, encompassing, if applicable, the wholesale distribution of products.<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>Medicinal products involve multiple and overlapping phases of distribution, starting with manufacturing in compliance with FDA\u2019s CGMPI <em>available at <\/em><a href=\"https:\/\/www.fda.gov\/drugs\/pharmaceutical-quality-resources\/current-good-manufacturing-practice-cgmp-regulations\">https:\/\/www.fda.gov\/drugs\/pharmaceutical-quality-resources\/current-good-manufacturing-practice-cgmp-regulations<\/a> (<em>see<\/em> No. 11), including quality assurance testing of the facility and quality control and product testing of raw materials, in-process samples, and finished products. Medicinal products must be labeled with essential ingredient, dosage, instruction, and warning information in accordance with FDA regulations, and be packaged to ensure the integrity of the product during distribution.\u00a0 During transportation, temperature-sensitive products may require specialized handling to prevent degradation in the stability or quality of the product.<\/p>\n<p>While FDA-regulated products may pass through distribution centers and wholesalers before reaching retail outlets or end-users, entities in the distribution chain must adhere to the Drug Supply Chain Security Act (DSCSA) throughout the distribution process. <em>See <\/em>21 U.S.C. \u00a7 301, <em>et seq.<\/em><\/p>\n<p>Section 202 of the DSCSA added section 582 to FDCA, which established product tracing, product identifier, authorized trading partner, and verification requirements for manufacturers, re-packagers, wholesale distributors, and dispensers to facilitate the tracing of products through the pharmaceutical distribution supply chain.\u00a0 Under the DSCSA, additional verification requirements apply to wholesale distributors, including relating to saleable returned pharmaceutical products. <em>See<\/em> <em>also<\/em> 21 U.S.C. \u00a7\u00a7 503(e), 503(e)(2)(A), 584(b).<\/p>\n<p>In the event of a product recall or safety concern, FDA has established procedures for the manufacturer to ensure the prompt removal of affected products in the distribution chain, including <a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/wholesale-distributor-verification-requirement-saleable-returned-drug-product-and-dispenser-0\">https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/wholesale-distributor-verification-requirement-saleable-returned-drug-product-and-dispenser-0<\/a> and the industry guidance entitled \u00a0\u201cEnhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act\u201d (DSCSA) <em>available at<\/em> <a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/enhanced-drug-distribution-security-package-level-under-drug-supply-chain-security-act\">https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/enhanced-drug-distribution-security-package-level-under-drug-supply-chain-security-act<\/a>.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Please briefly describe the pricing and reimbursement rules, if any, for medicinal products, medical devices, and food supplements in your jurisdiction?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>The Inflation Reduction Act (IRA) of 2022 aims to negotiate prices of certain high-spend medicinal products for Medicare (prescription benefit for people over 65).\u00a0 Following passage of the IRA (P.L. 117-169), the Centers for Medicare &amp; Medicaid Services (CMS) issued revised guidance on the requirements and procedures for calculating rebates and invoicing manufacturers for reimbursements owed under the Medicare Prescription Drug Inflation Rebate Program for certain products covered under Medicare Part B and Part D.\u00a0 The law requires pharmaceutical companies to pay a rebate to Medicare if they raise their prices for certain products faster than the rate of inflation. \u00a0Though the IRA has no direct impact on medications paid for by private insurance, it may lead to lowering of medicinal products that are sold in the private market as well.\u00a0 As of January 2025, two rounds of negotiations have identified 10 and 15 medicinal products that will be regulated under the IRA.<\/p>\n<p>Under the Medicaid Drug Rebate Program, manufacturers of medicinal products and medical devices are required to report the \u201cbest price\u201d offered to certain purchases, including Medicaid.\u00a0 The program requires a product manufacturer to enter into, and have in effect, a National Drug Rebate Agreement (NDRA) with the Secretary of the Department of Health and Human Services (HHS) in exchange for state Medicaid coverage of most of the manufacturer\u2019s products. When a manufacturer markets a new covered outpatient drug (COD), it must also submit product and pricing data concerning the product to CMS via the Medicaid Drug Programs (MDP) system.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">What legislative framework applies to the advertising for medicinal products, medical devices, and food supplements in your country?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>FDA regulates the advertising and promotion of prescription medicines, including that labeling must provide adequate directions for use and must not be false or misleading, including by material omissions.\u00a0 <em>See <\/em>21 U.S.C. \u00a7 352(a)(1), (f)(1),(n); <em>see<\/em> <em>also<\/em> 21 U.S.C. \u00a7 321(n).\u00a0 The applicable regulations impose requirements on patient\/consumer-facing prescription medication labeling and advertising, which must be a \u201ctrue statement of information in brief summary relating to the side effects, contraindications, and effectiveness\u201d of the product, and must present a \u201cfair balance\u201d between safety and effectiveness information.\u00a0 <em>See<\/em> 21 C.F.R. \u00a7 202.1; <em>see also<\/em> 21 C.F.R. \u00a7 202.1(e)(5)-(7).<\/p>\n<p>In addition, FDA has issued guidance documents outlining procedures of voluntary review for direct-to-consumer television advertisements of medicinal products, medical devices, and food supplements, as well as guidance on recommendations for correcting misinformation about medicinal products and medical devices on the internet and social media platforms.\u00a0 <em>See<\/em>, <em>e.g.<\/em>, <a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/internetsocial-media-platforms-correcting-independent-third-party-misinformation-about-prescription\">https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/internetsocial-media-platforms-correcting-independent-third-party-misinformation-about-prescription<\/a> and <a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/direct-consumer-prescription-drug-advertisements-presentation-major-statement-clear-conspicuous-and\">https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/direct-consumer-prescription-drug-advertisements-presentation-major-statement-clear-conspicuous<\/a>.\u00a0 FDA has also provided guidance that addresses questions regarding the development of FDA-regulated promotional labeling and advertisements for prescription reference products and prescription biosimilar products at \u00a0<a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/promotional-labeling-and-advertising-considerations-prescription-biological-reference-and-biosimilar\">https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/promotional-labeling-and-advertising-considerations-prescription-biological-reference-and-biosimilar<\/a>.<\/p>\n<p>Dietary supplements (food supplements) are defined as, in part, a product that is ingested by mouth to supplement the diet and contains one or more of the following ingredients: a vitamin; a mineral; an herb or other botanical; an amino acid; a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or a concentrate, a metabolite, a constituent, an extract, or any combination of the foregoing ingredients.\u00a0 21 U.S.C. \u00a7 321. Under the 1994 Dietary Supplement Health and Education Act (DSHEA) amending the FDCA, manufacturers are not required to submit dietary supplements to FDA for safety testing or approval prior to sale.\u00a0 In April 2024, FDA issued draft guidance on recommendations about Master Files (files containing identity, manufacturing, and\/or safety information relating to a new dietary ingredient) for reporting new dietary supplements, <em>accessible via<\/em> <a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/draft-guidance-industry-new-dietary-ingredient-notification-master-files-dietary-supplements\">https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/draft-guidance-industry-new-dietary-ingredient-notification-master-files-dietary-supplements<\/a>.<\/p>\n<p>FDA still regulates food supplements labeling, however, including mandating the placement and content of labels on advertised food supplements to state the: (1) identity (or the name of the food supplement); (2) net quantity of contents; (3) nutrition labeling; (4) ingredient list, and; (5) the name and place of business of the manufacturer, packer, or distributor.\u00a0 <em>See <\/em>21 C.F.R. \u00a7\u00a7 101.3(a), 101.105(a), 101.36, 101.4(a)(1), and 101.5.\u00a0 <em>See also <\/em><a href=\"https:\/\/www.fda.gov\/food\/dietary-supplements-guidance-documents-regulatory-information\/dietary-supplement-labeling-guide-chapter-i-general-dietary-supplement-labeling#:~:text=Five%20statements%20are%20required%3A%201,manufacturer%2C%20packer%2C%20or%20distributor\">https:\/\/www.fda.gov\/food\/dietary-supplements-guidance-documents-regulatory-information\/dietary-supplement-labeling-guide-chapter-i-general-dietary-supplement-labeling#:~:text=Five%20statements%20are%20required%3A%201,manufacturer%2C%20packer%2C%20or%20distributor<\/a>. Furthermore, manufacturers must have substantiation for any structure\/function claims describing the role of a dietary supplement in the structure and function of human bodies while refraining from explicitly or implicitly claiming to prevent, treat, mitigate, cure, or diagnose a disease. <em>See<\/em> 21 U.S.C. \u00a7 343(r)(6); 21 C.F.R. \u00a7 101.93(f)-(g); FDA, Structure\/Function Claims, Small Entity Compliance Guide <em>available at<\/em> <a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/small-entity-compliance-guide-structurefunction-claims\">https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/small-entity-compliance-guide-structurefunction-claims<\/a>.<\/p>\n<p>The Federal Trade Commission (\u201cFTC\u201d) also regulates advertising (other than labeling regulated by FDA) for food, food supplements, over-the-counter products, including that warnings be conveyed to consumers on product labels and labeling.\u00a0 <em>See<\/em> 21 C.F.R. \u00a7 201; 21 C.F.R. \u00a7 801. While the advertising of food and food supplements face fewer restrictions under the FTC, claims in advertising for these products must be true and cannot be misleading or unfair. Pursuant to the Federal Trade Commission Act, the FTC regulates a variety of \u201cunfair or deceptive acts or practices,\u201d including the dissemination of false advertisements directed to consumers.\u00a0 <em>See <\/em>15 U.S.C. \u00a7\u00a7 45, 52, 55; 21 U.S.C. \u00a7 352(r).<\/p>\n<p>Additionally, the Lanham Act creates liability for any person who, on or in connection with any goods or services, makes a false or misleading statement that, <em>inter alia<\/em>, \u201cin commercial advertising or promotion, misrepresents the nature, characteristics, qualities, or geographic origin of his or her or another person\u2019s goods, services, or commercial activities.\u201d 15 U.S.C. \u00a71125(A)(1)(B).\u00a0 State laws may further regulate deceptive practices by providing consumers a basis to bring their own lawsuit against advertisers, including class action lawsuits, <em>See<\/em>,<em> e.g.<\/em>, Cal. Bus. &amp; Prof. Code \u00a7\u00a7 17200, 17500.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">What laws apply to patents and trademarks for medicinal products, medical devices, and food supplements in your country?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>Patents and trademarks relating to medicinal products, medical devices, and food supplements are regulated by the United States Patent and Trademark Office (USPTO). Trademarks are governed by the USPTO under authority of the Lanham Act, 15 U.S.C. \u00a7\u00a7 1051, <em>et seq.,<\/em> while patent eligibility is governed by the Patent Act, 35 U.S.C. \u00a7\u00a7 101, <em>et seq. <\/em>\u00a0Utility patents protect useful, novel (35 U.S.C. \u00a7\u00a7 102), and non-obvious (35 U.S.C. \u00a7\u00a7 103) inventions for processes, machines, manufactured goods, compositions of matter, and improvements thereof. Under the Patent Act, the inventors (or assignees) have exclusivity rights for any article, process, or method covered by the patent claim.\u00a0 In addition, FDA publishes the Approved Drug Products with Therapeutic Equivalence Evaluations\u2014commonly known as the Orange Book\u2014that includes information on patents associated with products and their relevant expiration dates, <em>accessible via<\/em> <a href=\"https:\/\/www.fda.gov\/drugs\/drug-approvals-and-databases\/approved-drug-products-therapeutic-equivalence-evaluations-orange-book\">https:\/\/www.fda.gov\/drugs\/drug-approvals-and-databases\/approved-drug-products-therapeutic-equivalence-evaluations-orange-book<\/a>.<\/p>\n<p>In 2025, USPTO issued guidance narrowing the scope of abstract\u2011idea rejections under 35 U.S.C. \u00a7 101, which can benefit biotech and life sciences (e.g., diagnostics, biotech methods) by giving patentees stronger arguments to overcome eligibility challenges, <em>available here<\/em> <a href=\"https:\/\/www.uspto.gov\/subscription-center\/2025\/uspto-updates-subject-matter-eligibility-guidance-mpep\">USPTO updates subject matter eligibility guidance in the MPEP | USPTO<\/a>.<\/p>\n<p>Unlike term exclusivity for patents, trademark rights are indefinite so long as the mark remains used in commerce and the mark owner complies with statutory and regulatory requirements.\u00a0 Trademarks under the federal Lanham Act protect distinct words, symbols, logos, colors, slogans, sounds, package and store designs that are used in commerce to signify the source of a particular good or service to a relevant consumer in the marketplace.\u00a0 In addition to statutory trademark rights registered and regulated by the USPTO, common law trademark rights may accrue by virtue of use in commerce in connection with a particular good or service, but only in the geographic area(s) of use in commerce.<\/p>\n<p>Registering a trademark with the USPTO provides a rebuttable presumption that the registrant is the valid owner of the protectable trademark with exclusive use rights.\u00a0 Violations of such rights can include significant statutory damages under the federal Lanham Act.\u00a0 Issues relating to trademark applications and\/or registrations filed with the USPTO may be adjudicated by the Trademark Trial and Appeal Board (TTAB) in two types of hearings: (1) an <em>ex parte<\/em> appeal from denial of your application for registration by an examining attorney; and (2) an <em>inter partes<\/em> opposition, cancellation, concurrent use or interference proceeding.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Please briefly describe how patent infringements in relation to medicinal products and medical devices are addressed in your jurisdiction, including possible defense strategies and legal proceedings against patent infringements.<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>Infringement and invalidity contentions are usually governed by Local Rule or Standing Order (or the Case Management Plan), and may require accompanying document productions relating to prosecution histories, prior art, and ownership records. Infringement analysis typically requires two separate steps:\u00a0 claim construction and comparison of the accused product to the claims. <em>See, e.g.<\/em>, <em>Terlep v. Brinkmann Corp.<\/em>, 418 F.3d 1379, 1381 (Fed. Cir. 2005). In the first step, the court construes the claims as a matter of law to establish their meaning and scope. <em>See, e.g.<\/em>, <em>Markman v. Westview Instr., Inc.<\/em>, 52 F.3d 967, 979 (Fed. Cir. 1995) (<em>en banc<\/em>), <em>aff\u2019d<\/em>, 517 U.S. 370 (1996).\u00a0 Claim construction is determined at <em>Markman <\/em>hearings \u2013 named after <em>Markman v. Westview Instruments, Inc.<\/em>, 517 U.S. 370 (1996) wherein the Supreme Court held that judges, not juries, are responsible for determine the meaning of the words in patent claims. In determining the meaning of a claim term, several sources may be consulted, including \u201c\u2018the words of the claims themselves, the remainder of the specification, the prosecution history, and extrinsic evidence concerning relevant scientific principles, the meaning of technical terms, and the state of the art.\u2019\u201d <em>Phillips<\/em>, 415 F.3d at 1314 (citations omitted). \u00a0In the second step, the trier of fact determines whether the claims as thus construed read on the accused product, or if the accused product has a substantial equivalent element for each claim element not literally met.\u00a0 <em>See, e.g.<\/em>, <em>Cook Biotech Inc. v. Acell, Inc.<\/em>, 460 F.3d 1365, 1373 (Fed. Cir. 2006).<\/p>\n<p>A patent enjoys a statutory presumption of validity. \u00a0<em>See<\/em> 35 U.S.C. \u00a7 282.\u00a0 Similarly, each claim is individually presumed to be valid<a href=\"#_ftn1\" name=\"_ftnref1\">. As a result, any attempt to invalidate a patent claim must rest on clear and convincing evidence of invalidity<\/a>.\u00a0 Questions of validity cannot normally be determined as part of the claim construction process, as they turn on the scope of the claim, and no such regime is endorsed.\u00a0 <em>See, Phillips v. AWH Corp., 415 F.3d 1327 (Fed. Cir. 2005) (en banc)<\/em>. A claim may be invalid it is anticipated under 35 U.S.C. \u00a7 102, is only an obvious change over the prior art, judged from the viewpoint of a person of ordinary skill in that art under 35 U.S.C. \u00a7103, or is indefinite, vague, otherwise improper if it does not comply with the enablement, written description, and best mode requirements under 35 U.S.C. \u00a7 112<\/p>\n<p>In 2023, the U.S. Supreme Court issued an opinion addressing the enablement requirement under 35 U.S.C. \u00a7 112(a) in <em>Amgen Inc. v. Sanofi<\/em> (2023) 1598 U.S. 594. The Supreme Court held: \u201cIf a patent claims an entire class of processes, machines, manufactures, or compositions of matter, the patent\u2019s specification must enable a person skilled in the art to make and use the entire class. In other words, the specification must enable the full scope of the invention as defined by its claims. The more one claims, the more one must enable.\u201d <em>Id.<\/em> at 610. This holding may impact the validity of certain patents in legal proceedings, particularly relating to antibodies and other biologics.<\/p>\n<p>The United States Patent and Trademark Office issued a proposed rulemaking notice regarding significant changes to the procedures for instituting\u00a0<em>inter partes<\/em>\u00a0review (IPR) proceedings on October 16, 2025. The proposed rule seeks to formalize the PTAB\u2019s recent practice of discretionary denials emphasizing discretion and parallel district court litigation, reducing automatic institution. The proposed rules require petitioners to commit that they will not assert 35 U.S.C. \u00a7 102 or 35 U.S.C. \u00a7 103 invalidity in district court or before the ITC if they request IPR institution; they prevent institution when the same claims have already been upheld in other proceedings; and they discourage institution if a related court case is likely to reach a decision first.<a href=\"#_ftnref1\" name=\"_ftn1\"><\/a><\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Does your jurisdiction provide for restrictions on the use of trademarks for medicinal products, medical devices, food, and food supplements?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>Although FDA\u2019s labeling requirements for medicinal products, medical devices, foods, and food supplements may further restrict the use of marks on regulated goods and products, in the United States, \u201ca mark tells the public who is responsible for a product.\u201d <em>Jack Daniel\u2019s Properties, Inc. v. VIP Prod. LLC<\/em> (2023) 599 U.S. 140, 146.\u00a0 Marks must be used in commerce and distinctive to be eligible for trademark protection under the federal Lanham Act.\u00a0 In evaluating trademark protection eligibility, the distinctiveness of a trademark is generally as: (1) arbitrary\/fanciful, (2) suggestive, (3) descriptive, or (4) generic.\u00a0 <em>I<\/em><em>nwood Laboratories, Inc. v. Ives Laboratories, Inc.<\/em> (1982) 456 U.S. 844, 863.\u00a0 If a mark is categorized as either arbitrary\/fanciful or suggestive, it is considered inherently distinctive, and exclusivity rights are determined by priority of use in commerce.\u00a0A trademark that is categorized as descriptive may still be protectable\u00a0as a trademark if it has acquired a secondary meaning to relevant consumers in the marketplace. Trademark classes categorize goods and services into different groups. Medicinal products (pharmaceutical), medical and veterinary supplies, dietary supplements, and sanitary preparations are included in trademark\u00a0class 5.<\/p>\n<p>Generic terms are ineligible for protection because they refer to a general class of products rather than indicating a unique source.\u00a0 \u201cA generic term is one that refers, or has come to be understood as referring, to the genus of which the particular product is a species.\u201d <em>Abercrombie &amp; Fitch Co. v. Hunting World, Inc.<\/em> (2d Cir. 1976) 537 F.2d 4, 9. When a suggestive or fanciful term has become generic as a result of a manufacturer\u2019s own advertising efforts, trademark protection will be denied save for those markets where the term still has not become generic and a secondary meaning has been shown to continue. <em>Id., <\/em>at 10, <em>citing Bayer Co. v. United Drug Co.<\/em> (2d Cir. 1921) 272 F. 505; <em>DuPont Cellophane Co. v. Waxed Products Co.<\/em> (2d Cir. 1936) 85 F.2d 75, <em>cert. denied<\/em>, 299 U.S. 601.<\/p>\n<p>Relating to the distinctiveness element for trade dress protection under the federal Lanham Act is the functionality doctrine, which provides that functional features of a product cannot serve as a trademark.\u00a0 \u201cIn general terms, a product feature is functional,\u201d and cannot serve as a trademark, \u201cif it is essential to the use or purpose of the article or if it affects the cost or quality of the article,\u201d that is, if exclusive use of the feature would put competitors at a significant non-reputation-related disadvantage. <em>Inwood Laboratories, Inc. v. Ives Laboratories, Inc.<\/em> (1982) 456 U.S. 844, 850, n. 10.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Please briefly describe the product liability regime for medicinal products, medical devices, and food supplements in your country.<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>Medicinal products, medical devices, and food supplements are all subject to regulation by FDA, with food supplements being regulated as foods not pharmaceuticals. The product liability regime in the United States is based on compensation for alleged defects in the products. An injury on the plaintiff is usually a requirement because based on the Economic Loss Rule, \u201ca plaintiff is barred from recovering in tort when the claimed damages are solely grounded on economic loss\u201d <em>KeraLink Int\u2019l, Inc. v. Geri-Care Pharms. Corp.<\/em>, 60 F.4th 175, 184 (4th Cir. 2023). Medical devices are regulated differently depending on perceived risk\u2014Class I, Class II, and Class III.<\/p>\n<p>The U.S. product liability regime is primarily governed by state tort law, rather than a single national statute. Plaintiffs who allege product liability claims do so under theories of negligence or strict liability. Under theories of Negligence, consumers usually need to how: (1) \u201cthe manufacturer owed plaintiff a duty to exercise reasonable care\u201d; (2) the manufacturer breached \u201cthat duty by fail[ing] to use reasonable care so that a product is rendered defective,\u00a0<em>i.e.<\/em>\u00a0reasonably certain to be dangerous\u201d; (3) \u201cthe defect was the proximate cause of the plaintiff&#8217;s injury\u201d; and (4) the plaintiff sustained \u201closs or damage.\u201d <em>Colon v. BIC USA, Inc.<\/em>, 199 F. Supp. 2d 53, 82 (S.D.N.Y. 2001). Food and dietary supplements are considered defective if these are contaminated. Dietary supplements can also be considered adulterated, which means that it \u201cbears or contains any poisonous or deleterious substance which may render it injurious to health.\u201d 21 U.S.C. \u00a7 342(a). Consumers usually seek compensatory and punitive damages for their injury.<\/p>\n<p>&nbsp;<\/p>\n<p>Product liability claims in the life sciences sector are sometimes aggregated through procedural mechanisms such as class actions, multidistrict litigation (MDL) in federal courts, and coordinated mass tort programs in state courts. These frameworks allow for the consolidation of large numbers of cases involving common factual issues, like alleged defects, for purposes of pretrial proceedings, including discovery, and at times, dispositive motions. While aggregation can promote efficiency and consistency, it often increases leverage for plaintiffs by concentrating claims. Defendants can face significant early burdens, including broad discovery obligations and pressure to develop unified defense strategies across large inventories of claims.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Please provide a short overview of risks of liability (criminal liability, serious administrative \/ civil liability) and enforcement practice with regards to medicinal products (including biologicals), medical devices, foods, and food supplements.<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>The risk of liability most commonly seen is civil liability.\u00a0 There is no uniform substantive federal law that governs product liability claims across the United States; rather, each state has its own substantive law that will be applied.\u00a0 While there is no substantive federal law, manufacturers are able to preempt certain claims brought by plaintiffs by asserting, <em>inter alia<\/em>, compliance with government requirements or that plaintiffs are attempting to impose obligations different that those imposed by FDA.<\/p>\n<p>There is also a trend wherein state Attorneys General seek civil penalties from product manufacturers under consumer protection theories of liability.\u00a0 Typically, individual plaintiffs will bring product liability causes of action first.\u00a0 Then, once those cases are litigated, certain attorneys general will seek to recover certain damages alleging that they are vindicating the rights of their citizens.<\/p>\n<p>While criminal procedures are rare, criminal liability in the life sciences sector is primarily enforced under the Federal Food, Drug, and Cosmetic Act, with the U.S. Department of Justice, often in coordination with the FDA. Companies and individuals may face charges under the \u201cresponsible corporate officer\u201d or <em>Park Doctrine<\/em>, where individuals can be held criminally liable even without proof of intent, based solely on their authority to prevent or correct violations of causing adulteration or misbranding of food, drugs, and medical devices. Felony exposure may arise where there is evidence of intent to defraud or mislead.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Does your jurisdiction provide for a specific legislative and regulatory framework for digital health applications (e.g., medical apps)? If yes, please briefly describe the relevant framework.<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>Software as a Medical device is currently regulated by FDA. It covers \u201csoftware intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.\u201d Similarly, FDA has released a guide on the regulation of Mobile Medical Applications, which it considers to be medical devices in certain scenarios. <em>See <\/em><em>Policy for Device Software Functions and Mobile Medical Applications Guidance<\/em>. FDA focuses on the intended use of the mobile application, and it covers applications that are used \u201cfor the diagnosis of disease or other conditions, or the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or any function of the body . . . ,\u201d falling under section 201(h) of the FD&amp;C Act.<\/p>\n<p>For applications and software that pose minimal risk to consumers, like functions providing periodic educational or motivation information to patients, FDA will exercise enforcement discretion and not expect these manufactures to submit pre-market applications. In contrast, applications and software that pose a risk to a patient\u2019s safety if they were to malfunction are the focus of FDA\u2019s regulatory oversight. These include applications that use a mobile device\u2019s features (e.g., camera, vibration function, flashlight, etc.), like ones that use mathematical algorithms to provide assessments of the risk of lesion on a patient. These applications and software are considered medical devices and regulated as such.<\/p>\n<p>Like many products, regulations and liability of digital health applications may expand to other federal and state laws, including data privacy and security requirements, like The Health Insurance Portability and Accountability Act (HIPAA), consumer protection laws enforced by the Federal Trade Commission, and reimbursement rules tied to federal healthcare programs.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Does your jurisdiction provide for laws or certain legal measures to ensure the supply of medicinal products and medical devices, or are such rules envisaged in the future? If yes, please briefly describe those rules.<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>FDA issued guidance for manufactures to provide FDA with notice regarding permanent discontinuance or interruption of certain medical devices. <em>See Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&amp;C Act<\/em>. The guidance mentions devices that are critical to public health during a Public Health Emergency, including devices that are life supporting or meant to use in emergency medical care. FDA maintains a list of these reports, known as the shortage list. Section 506J requires a notification of discontinuance or interruption in the supply of a product six months in advance of such event. The\u00a0Resilient Supply Chain Program (RSCP) manages FDA\u2019s activities anticipating and preventing the disruptions to the medical device supply chain, including maintaining the shortage list. <em>See<\/em> https:\/\/www.fda.gov\/medical-devices\/medical-device-supply-chain-and-shortages\/506j-device-list.<\/p>\n<p>The guidance only applies \u201cduring, or in advance of, a public health emergency declared by the Secretary under section 319 of the Public Health Service Act.\u201d <em>Id<\/em>. With the Covid-19 public emergency expiring on May 11, 2023, the requirement is no longer in effect. FDA does encourage manufacturers to voluntarily submit 506J Notifications.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Are there any specific compliance standards in your jurisdiction for the marketing of medicinal products and medical devices (e.g., codes of conducts of industry associations, etc.)? If yes, please give a brief overview of the relevant standards.<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>The Food, Drug, and Cosmetic Act (FDCA) and the Federal Trade Commission Act (FTCA) generally govern advertisements of medical devices and products. More specifically, FTCA prohibits the use of unfair or deceptive acts or practices that affect commerce and the false advertisement of cosmetics, pharmaceuticals, devices, food, or services. <em>See<\/em> 15 U.S.C. \u00a7\u00a7 45, 52. FDA regulates labeling of pharmaceuticals, usually requiring the name of product, active ingredients, and proper use, among others. 21 CFR \u00a7 201.1. State law also usually applies to misleading advertisement of pharmaceuticals and medical devices. <em>See, e.g.,<\/em> N.J.S.A \u00a7 13:39-7.14.<\/p>\n<p>FDA stablished what is known as the Bad Ad Program, which \u201cis an outreach program designed to help healthcare providers recognize potentially false or misleading prescription drug promotion.\u201d The program allows for reporting of potentially false or misleading advertisement. The program is run by FDA\u2019s Office of Prescription Drug Promotion (OPDP). The OPDP regulates promotion of prescription pharmaceuticals made on behalf of manufacturers or distributors. Promotions cannot be false of misleading, have balance regarding efficacy and risk information, and reveal material facts.<\/p>\n<p>While not binding on manufactures as it has no enforcement powers, the Pharmaceutical Research and Manufacturers of America has issued guidelines on direct to consumer communications. The guidelines are generally written to comply requirements already put in place by FDA and FTC. Some of the guidelines include:<\/p>\n<ul>\n<li>Including alternatives to medicine, like exercise, in televised or printed advertisements<\/li>\n<li>Submitting advertisements to be televised to FDA prior to airing<\/li>\n<li>Respecting the seriousness of diseases and medicines in advertisements<\/li>\n<\/ul>\n<p>Additional transparency obligations, such as the Federal Open Payments program (Sunshine Act), require disclosure of transfers of value to healthcare providers, like meal and lodging. Together, these frameworks create a comprehensive compliance environment combining regulatory enforcement with industry-driven standards.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Please state 3-5 key decisions by courts or regulatory authorities that have been issued recently and that are relevant for the life sciences sector.<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><ul>\n<li>FDA issued a guidance covering products going through the 510(k) process that contain the label of being sterile. FDA recognizes that certain methods like dry heat and radiation are established, and FDA has experience working with them, but more novel methods carry a substantial risk of inadequate sterility. The guidance states that FDA intends to inspect the manufacturing facility before clearing a 510(k) for a device that is sterilized by a novel sterilization process.<\/li>\n<li><em>Loper Bright Enterprises v. Raimondo<\/em>, 603 US 369 (2024). The case where the United States Supreme Court overruled what was known as the <em>Chevron<\/em> Prior to <em>Loper<\/em> courts would generally defer to federal agencies when interpreting and implementing statutory authority.<\/li>\n<li><em>American Clinical Laboratory Association v. U.S. Food and Drug Administration<\/em>, No. 4:24-CV-479 (E.D. Tex.) (March 31, 2025), Dkt. No. 93. Relying in part on <em>Loper Bright<\/em>, a federal court vacated an U.S. Food and Drug Administration rule that would have regulated laboratory-developed tests as medical devices, holding that the agency exceeded its statutory authority under the Administrative Procedure Act. The decision brought uncertainty regarding the future regulation of LDTs, including appeals, FDA enforcement, and congressional grant of explicit authority.<\/li>\n<li><em>Hybrid Pharma LLC v. Food and Drug Administration<\/em>, No. 0:2024cv62413 (S.D. Fla. 2026), Dkt. No. 29. The court found that an FDA\u2019s denial of a citizen petition constituted \u201cfinal agency action\u201d subject to judicial review under the Administrative Procedure Act. The court allowed the challenge to proceed, distinguishing prior precedent by finding that, although warning letters themselves are typically not reviewable, the agency\u2019s response to a citizen petition is.<\/li>\n<li>The FDA also recently issued guidance on addressing clinical decision support (CDS) software and other digital health tools, including AI-enabled applications. The guidance clarifies the agency\u2019s risk-based approach, expanding categories of lower-risk products for which it intends to exercise enforcement discretion. At the same time, the FDA continues to develop frameworks for lifecycle oversight of higher-risk AI\/ML-enabled devices, including expectations around updates, validation, and transparency. These developments reflect a broader effort to balance innovation and faster market access with regulatory safeguards for clinically impactful technologies.<\/li>\n<\/ul>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">What, if any, are the key legal and regulatory trends in your jurisdiction with regards to the digitalization of the local healthcare system and with regards to the use of artificial intelligence in the life sciences sector? Please briefly describe.<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>With more states passing comprehensive consumer privacy laws, it is still unclear how it will affect local health care systems and their use of artificial intelligence (AI). With the use AI becoming more and more popular, including it possibly being used for patient diagnosis or other applications, local health care systems would need to comply with state laws regulating the use of patient\u2019s private information.<\/p>\n<p>There are currently 20 states with these comprehensive consumer privacy laws, and some of them (like California\u2019s Privacy Act Right) directly address medical information and protected health information. While some of these privacy laws do not necessarily address artificial intelligence, these laws have opt-in procedures or consent requirements before some data processors are able to process the user\u2019s data. This will likely make it more difficult for local healthcare systems to comply with these laws, but also implement the use of AI in their practice.<\/p>\n<p>Generally, regulators are focusing on transparency, bias mitigation, and data integrity, particularly where AI tools influence clinical decision-making or patient outcomes. While there is no AI-specific healthcare statute yet, policy development is accelerating through guidance, enforcement actions, and broader federal AI initiatives.<\/p>\n<p>Recent trends and discussions reflect a balancing of innovation with risk management, relying on flexible regulatory tools that can adapt to rapidly evolving technologies.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Please briefly highlight 3-5 key developments or trends in your jurisdiction with regards to the life sciences sector as you consider them relevant. This may include legislative proposals, market activity, etc.<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><ul>\n<li>FDA has seen an increase of the use of AI during the life cycle of various products. In January of this year FDA published guidance on the use of AI labeled \u201cConsiderations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products.\u201d The guidance provides recommendations on the use of AI to \u201cproduce information or data intended to support regulatory decision-making regarding safety, effectiveness, or quality for drugs.\u201d<\/li>\n<li>There is a continuing trend in the filing of lawsuits regarding consumer products in contrast with traditional medical products and devices. These include items like certain watch bands, bandages containing adhesives, and boxed drink containers.<\/li>\n<li>Supreme Court of the United States granted certiorari in\u00a0<em>Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc.<\/em>(No. 24-889). The court will determine when induced infringement liability can arise for a generic drug launched with a \u201cskinny label\u201d that carves out patented uses. The case stems from a Federal Circuit decision allowing inducement claims to proceed based on the totality of allegations, which includes labeling and public statements, even where a generic label may have omitted the patented indication. The Court\u2019s decision is expected to clarify the interaction between FDA carveout pathways and patent law.<\/li>\n<li>Rapid growth of GLP-1 and other obesity medication has become one of the most significant drivers of activity in the U.S. life sciences sector. This surge has created downstream legal and regulatory issues, including disputes over reimbursement, coverage limitations, and the role of compounding pharmacies during shortages. Regulators, including the FDA, have increased scrutiny of compounding practices and marketing claims tied to these products. As a result, some areas are now generating not only commercial opportunity but also heightened enforcement and litigation risk.<\/li>\n<li>Following the 2023 amendments to Federal Rule of Evidence 702, courts have increasingly emphasized that the proponent of expert testimony must establish admissibility by a preponderance of the evidence, reinforcing the trial judge\u2019s gatekeeping role. Courts are more frequently rejecting the notion that challenges to an expert\u2019s methodology go merely to weight, instead excluding opinions where reliability or application of methodology is insufficiently demonstrated.<\/li>\n<li>Courts have refused to expand the definition of public nuisance claims to cover certain life sciences matters. The Supreme Court of Maryland was recently asked whether \u201cthe licensed dispensing of, or administration of benefit plans for,\u201d a controlled substance\u2014in this case opioids\u2014could give rise to a claim for public nuisance. <em>See Express Scripts, Inc., et al. v. Anne Arundell Cnty, MD<\/em>, Case No. Misc. No. 1 (S. Ct. Md. Mar. 23, 2026). The court held that public nuisance claims can only seek injunctive relief, not compensatory relief. Moreover, given the extensive regulatory structure surrounding opioids, there was not a need to expand traditional tort concepts to this scenario.<\/li>\n<\/ul>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\r\n<div class=\"word-count-hidden\" style=\"display:none;\">Estimated word count: <span class=\"word-count\">9765<\/span><\/div>\r\n\r\n\t\t\t<\/ol>\r\n\r\n<script type=\"text\/javascript\" src=\"\/wp-content\/themes\/twentyseventeen\/src\/jquery\/components\/filter-guides.js\" async><\/script><\/div>"}},"_links":{"self":[{"href":"https:\/\/my.legal500.com\/guides\/wp-json\/wp\/v2\/comparative_guide\/137354","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/my.legal500.com\/guides\/wp-json\/wp\/v2\/comparative_guide"}],"about":[{"href":"https:\/\/my.legal500.com\/guides\/wp-json\/wp\/v2\/types\/comparative_guide"}],"wp:attachment":[{"href":"https:\/\/my.legal500.com\/guides\/wp-json\/wp\/v2\/media?parent=137354"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}