ArticleFDA Launches First Drug Shortage Mobile AppFDA launched its first mobile app to speed public access to information about drug shortages.United StatesFood, Drugs, Healthcare, Life SciencesJones Day
ArticleFDA Leads The Way On FluoropolymersOn August 6, 2025, the U.S. Food and Drug Administration (FDA) became the latest governmental agency to confirm that fluoropolymers are both safe and necessary. After an independent safety review...United StatesFood, Drugs, Healthcare, Life SciencesAkin
ArticleFDA Makes Tentative Determinations That Ecamsule And Enzacamene Are Not GRASE For Use In OTC Sunscreen ProductsThrough dual notices in the February 25, 2015, Federal Register, FDA issued proposed sunscreen orders under the FD&C Act, as amended by the Sunscreen Innovation Act...United StatesFood, Drugs, Healthcare, Life SciencesJones Day
ArticleFDA May Consider Heart Health Risks Of Testosterone DrugsFDA recently convened a joint advisory committee meeting on testosterone replacement therapy.United StatesFood, Drugs, Healthcare, Life SciencesJones Day
ArticleFDA Moves Forward On FluoropolymersOn August 6, 2025, the U.S. Food and Drug Administration (FDA) became the latest governmental agency to confirm that fluoropolymers are both safe and necessary.United StatesFood, Drugs, Healthcare, Life SciencesAkin
ArticleFDA Proposes Rule Banning Electrical Stimulation Devices Used To Treat Self-Injurious Or Aggressive BehaviorIn the April 25, 2016, Federal Register, FDA proposed a ban on electrical stimulation devices used to treat aggressive or self-injurious behavior. United StatesFood, Drugs, Healthcare, Life SciencesJones Day
ArticleFDA Proposes Rule On Accreditation Of Third-Party Auditors Under FSMAIn the July 24, 2015, Federal Register, FDA issued a proposed rule to amend the proposed rule, "Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications."United StatesFood, Drugs, Healthcare, Life SciencesJones Day
ArticleFDA Proposes Rule To Clarify Regulatory Status Of Products Derived From Tobacco And Amendments To Regulations Regarding "Intended Uses"In the same notice, FDA is proposing to amend its existing "intended use" regulations for drugs and devices. United StatesFood, Drugs, Healthcare, Life SciencesJones Day
ArticleFDA Proposes Rule To Establish Additional Requirements On "Gluten-Free" Labeling For Certain FoodsAs discussed above, in the November 18, 2015, Federal Register, FDA proposed to establish additional requirements concerning "gluten-free" labelling...United StatesFood, Drugs, Healthcare, Life SciencesJones Day
ArticleFDA Proposes Rule To Establish Requirements For The Electronic Filing Of EntriesThe requirement would apply to information material to the admissibility determination for FDA-regulated products being imported or offered for import. United StatesFood, Drugs, Healthcare, Life SciencesJones Day
ArticleFDA Proposes Rules For 505(b)(2) Applications And ANDAsAccording to FDA, it has been implementing the MMA directly from the statute for several years and now seeks to amend its regulations to codify current practice and policy.United StatesFood, Drugs, Healthcare, Life SciencesJones Day
ArticleFDA Proposes To Amend Regulations For Registration Of Food FacilitiesIn the April 9, 2015, Federal Register, FDA announced its proposal to amend regulations for registration of foreign food facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States. United StatesFood, Drugs, Healthcare, Life SciencesJones Day
ArticleFDA Proposes To Remove Two Regulations On Biological ProductsIn the July 2, 2015, Federal Register, FDA proposed to remove two regulations dictating procedures for FDA's review and classification of biological products licensed before July 1, 1972. United StatesFood, Drugs, Healthcare, Life SciencesJones Day
ArticleFDA Provides Direction On "Dear Doctor" LettersOn January 16, 2014, the Food and Drug Administration (FDA) issued a final guidance document for industry providing specific recommendations on the content and format of Dear Health Care Provider (DHCP or "Dear Doctor") letters. United StatesFood, Drugs, Healthcare, Life SciencesReed Smith
ArticleFDA Publishes Certification Fees For Export Certificates Of Animal FoodIn the September 10, 2015, Federal Register, FDA announced the fees for issuing export certifications for animal food, which may reach up to $175 for each certificate. United StatesFood, Drugs, Healthcare, Life SciencesJones Day
ArticleFDA Publishes Draft Compliance Policy Guide For Crotalaria Species Seeds In GrainsIn the September 21, 2015, Federal Register, FDA announced the availability of a draft Compliance Policy Guide ("CPG") titled "Compliance Policy Guide Sec. 100.101 Crotalaria spp. Seeds in Grains."United StatesFood, Drugs, Healthcare, Life SciencesJones Day
ArticleFDA Publishes Draft Recommendations For Study Data Standardization PlansIn the May 18, 2015, Federal Register, FDA published draft recommendations for sponsors' use when creating Study Data Standardization Plans.United StatesFood, Drugs, Healthcare, Life SciencesJones Day
ArticleFDA Publishes List Of Approved PMA ApplicationsIn the February 11, 2015, Federal Register, FDA published a list of premarket approval applications that were approved between July 1, 2014, and September 30, 2014. United StatesFood, Drugs, Healthcare, Life SciencesJones Day
ArticleFDA Publishes List Of Approved PMAs - November 2015In the November 18, 2015, Federal Register, FDA published a list of premarket approval applications ("PMAs") that have been approved between July 1, 2015, and September 30, 2015. United StatesFood, Drugs, Healthcare, Life SciencesJones Day
ArticleFDA Publishes New Documents Updating Docket On Proposed Rule To Amend Labeling Requirements For Conventional Foods And Dietary SupplementsIn the September 10, 2015, Federal Register, FDA announced the availability of documents updating the administrative docket of the proposed rule amending FDA's labeling regulations for conventional foods and dietary supplements. United StatesFood, Drugs, Healthcare, Life SciencesJones Day