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Your search for ‘Hyman, Phelps, & McNamara’ returned 249 results

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  • Article

    California's New Allergen-Disclosure Law: A Sign Of Things To Come?

    On October 13, 2025, Governor Gavin Newsom signed into law SB 68, titled "Allergen Disclosure for Dining Experiences Act," officially creating a statewide requirement for certain restaurants to disclose major food allergens on their menus.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Hyman, Phelps, & McNamara
    Hyman, Phelps, & McNamara
  • Article

    FDA Sort-of Commits To Meet With Generic Drug Manufacturers That Have Received Warning Letters

    The Guidance also commits FDA to some deadlines for when requests to meet will be accepted or denied, and for when meetings will be held if granted.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Hyman, Phelps, & McNamara
Hyman, Phelps, & McNamara
  • Article

    From GRP To SIUU – The Evolution Of FDA Guidance On Off-Label Dissemination Of Scientific Information

    Yesterday, FDA published a new Draft Guidance, "Communications from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products...
    United StatesFood, Drugs, Healthcare, Life Sciences
    Hyman, Phelps, & McNamara
    Hyman, Phelps, & McNamara
  • Article

    Into The Ashtray: FDA's Previous Proposal To Ban Menthol Cigarettes

    On January 21, 2025, the Trump administration withdrew FDA's proposed ban on menthol cigarettes, which the Biden administration initially introduced in 2022.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Hyman, Phelps, & McNamara
    Hyman, Phelps, & McNamara
  • Article

    Ninth Circuit Sends USDA's Agricultural Marketing Service ("AMS") Back To Drawing Board On Some Aspects Of The BE Labeling Rule

    As we previously reported, nearly four years ago, the Natural Grocers, Citizens for GMO Labeling, Label GMOs, Rural Vermont, Good Earth Natural Foods, Puget Consumers Co-op, and the Center for Food Safety...
    United StatesFood, Drugs, Healthcare, Life Sciences
    Hyman, Phelps, & McNamara
    Hyman, Phelps, & McNamara
  • Article

    Reports Document FDA Review Delays: What Drugmakers Should Know Now

    Recent reductions in force (RIFs) and leadership changes at FDA are already affecting key agency functions—and as the administration plans a broader reorganization, the impact will likely grow.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Hyman, Phelps, & McNamara
    Hyman, Phelps, & McNamara
  • Article

    What We're Watching For In The Senate Confirmation Hearings To Consider Robert F. Kennedy, Jr. To Be Secretary Of HHS

    The confirmation hearings for Robert F. Kennedy, Jr. to lead the Department of Health and Human Services kick off at 10 am on January 29 and promise to have a packed agenda.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Hyman, Phelps, & McNamara
    Hyman, Phelps, & McNamara
  • Article

    While FDA Suffers Staffing Cuts, Nondelegation Case In SCOTUS Is Latest Legal Challenge To Curb Agency Powers

    Last June, the United States Supreme Court issued four landmark decisions that curbed executive agency powers. Those decisions are changing the way agencies,
    United StatesFood, Drugs, Healthcare, Life Sciences
    Hyman, Phelps, & McNamara
    Hyman, Phelps, & McNamara
  • Article

    FDA's New Medical Gas Guidance Is No Laughing Matter

    FDA recently published draft guidance explaining how medical gas manufacturers should comply with new regulations that become effective today, December 18, 2025.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Hyman, Phelps, & McNamara
    Hyman, Phelps, & McNamara
  • Article

    HP&M Files Comments Opposing FDA's Proposed LDT Rule

    On Monday, Hyman, Phelps & McNamara, P.C. filed comments on behalf of the Coalition to Preserve LDT Access and Innovation in response to FDA's proposed...
    United StatesFood, Drugs, Healthcare, Life Sciences
    Hyman, Phelps, & McNamara
    Hyman, Phelps, & McNamara
  • Article

    Going To 11: New Subsections At CDER's Office Of Pharmaceutical Quality Are Important Piece Of FDA's Inspection And Enforcement Strategy

    The word last week was that FDA is re-organizing the Office of Pharmaceutical Quality (OPQ) within the Center for Drug Evaluation and Research (CDER).
    United StatesFood, Drugs, Healthcare, Life Sciences
    Hyman, Phelps, & McNamara
    Hyman, Phelps, & McNamara
  • Article

    Will FDA's Section 804 "Enhancements" Really Speed Up Drug Imports From Canada?

    On May 21, FDA announced "enhancements" to the Section 804 import program (SIP). Section 804 of the Federal Food, Drug, and Cosmetic Act provides a pathway for certain prescription drug imports from Canada.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Hyman, Phelps, & McNamara
    Hyman, Phelps, & McNamara
  • Article

    You've Got Mail, And Twice The Time To Respond! Two Device Companies Find Themselves With 30 Business Days To Respond To FDA's Warning Letters

    No company wants to be on the receiving end of a Warning Letter, which is FDA's primary tool for communicating to a company that it has been found to be in significant violation of regulatory requirements
    United StatesFood, Drugs, Healthcare, Life Sciences
    Hyman, Phelps, & McNamara
    Hyman, Phelps, & McNamara
  • Article

    As 2024 Closed, FDA Issued A Proposed Rule On Asbestos Testing; Implementation Of MoCRA Remains Much Slower Than Planned

    A little over two years ago, the Modernization of Cosmetic Regulation Act (MoCRA) was (at long last) enacted. The passing of the law which, among other...
    United StatesFood, Drugs, Healthcare, Life Sciences
    Hyman, Phelps, & McNamara
    Hyman, Phelps, & McNamara
  • Article

    HHS Divided: Can Consumers Be Trusted With Low-Risk Products?

    Since his appointment, he has indicated his desire to allow individuals to try healing themselves as they see fit, regardless of FDA approval, stating, "We want to make sure that information is out there.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Hyman, Phelps, & McNamara
    Hyman, Phelps, & McNamara
  • Article

    Real Food, Healthy Kids – And It's Not An Act

    Actually, it is. No sooner had FDA flagged its intent to maybe eventually hammer out a federal definition of ultra-processed foods than California leapfrogged ahead with the Real Food, Healthy Kids Act (a/k/a AB 1264).
    United StatesFood, Drugs, Healthcare, Life Sciences
    Hyman, Phelps, & McNamara
    Hyman, Phelps, & McNamara
  • Article

    Decades Of LDT Tension Leads To An Epic Three-Hour Oral Argument

    The multi-decade battle over FDA's power to regulate Laboratory Developed Tests (LDTs) had its day in court earlier this week. On February 19, 2025, Judge Sean Jordan in the Eastern District of Texas.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Hyman, Phelps, & McNamara
    Hyman, Phelps, & McNamara
  • Article

    FDA Issues First Draft Guidance In The Countdown To QMSR

    On January 31, 2024, FDA issued the final rule revising 21 C.F.R. Part 820, which, upon taking effect, will be referred to as the Quality Management System Regulation (QMSR) (see our prior blog post here).
    United StatesFood, Drugs, Healthcare, Life Sciences
    Hyman, Phelps, & McNamara
    Hyman, Phelps, & McNamara
  • Article

    Silence Isn't Golden: Two Executives Convicted In First Criminal Prosecution Under The Consumer Product Safety Act

    Although the Consumer Product Safety Act (CPSA) has been around for over 50 years to "protect the public against unreasonable risks of injury associated with consumer products...
    United StatesConsumer Protection
    Hyman, Phelps, & McNamara
    Hyman, Phelps, & McNamara
  • Article

    CDER's Office Of Compliance Kicks Off Annual Report Season With Rundown Of 2023's Major Public Health Enforcement Initiatives

    The Office of Compliance (OC) at FDA's Center for Drug Evaluation and Research (CDER) had a role in many of the major public health...
    United StatesFood, Drugs, Healthcare, Life Sciences
    Hyman, Phelps, & McNamara
    Hyman, Phelps, & McNamara

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