• where experts go to learn about FDA
  • Year: 2025

    • Hyman, Phelps & McNamara Enters its 45th Year Continuing to Expand its Capabilities to Meet Client NeedsApril 6th, 2025

      Hyman, Phelps & McNamara (HPM) marks its 45th Anniversary year by welcoming three accomplished professionals who reinforce the depth and breadth of the firm’s FDA and DEA practices. Naomi Lowy joins HPM as a Principal Drug Regulatory Expert after 18 years at the FDA’s Center for Drug …

    • While FDA Suffers Staffing Cuts, Nondelegation Case in SCOTUS Is Latest Legal Challenge to Curb Agency PowersApril 4th, 2025

      Last June, the United States Supreme Court issued four landmark decisions that curbed executive agency powers. Those decisions are changing the way agencies, including FDA, exercise their rulemaking and enforcement authorities. Regardless of your position on the correctness of the holdings or the reasoning behind …

    • Governmentally Recognized as SafeApril 3rd, 2025

      That’s a play on an old acronym, in service of a point. A few weeks ago, HHS released a press release stating that FDA had been directed “to explore potential rulemaking to revise its Substances Generally Recognized as Safe (GRAS) Final Rule and related guidance …

    • The Preserve Access to Affordable Generics and Biosimilars Act: It’s Back! And Bigger and Bolder than Before!April 2nd, 2025

      Last week, U.S. Senators Amy Klobuchar (D-MN) and Chuck Grassley (R-IA) announced the introduction of two bills we’ve seen before: (1) S. 1096, the Preserve Access to Affordable Generics and Biosimilars Act; and (2) S. 1095, the Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation …

    • More Uncertainty and Less Advice from FDA Means Companies will Need to Even More Carefully Chart their own Course to Achieve their GoalsApril 2nd, 2025

      Trade and national press have reported that recent changes in FDA staffing levels have already led to  slower responses to calls and emails.  According to reports, which were published before the most recent reports of HHS staff level reductions and tumultuous changes in leadership, FDA …

    • Federal District Court Vacates FDA’s Laboratory Developed Tests Final RuleApril 1st, 2025

      On March 31, 2025, U.S. District Judge Sean D. Jordan ordered that FDA’s Laboratory Developed Tests (LDT) Final Rule be vacated and set aside, in its entirety. That Rule sought to codify FDA’s view that LDTs are medical devices subject to FDA regulation under the …

    • It’s a Bird, It’s a Plane, It’s Operation Stork SpeedMarch 31st, 2025

      On March 18, 2025, the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) launched a significant initiative called Operation Stork Speed to bolster the availability and safety of infant formula in the United States (link, link).  This initiative …

    • Adios to Synthetic Colors in Food?March 27th, 2025

      Our good friends Virginia and West Virginia have become the first states in the nation to restrict the availability of foods containing certain synthetic colors (or in FDA parlance, certain colors subject to certification). You can read more about the particulars here and here. Although …

    • Medical Device Notification Warns of Continued Data Integrity ConcernsMarch 26th, 2025

      Last year, FDA issued a letter to the medical device industry warning medical device firms of concerns related to fraudulent and unreliable laboratory testing data in premarket submissions, which we blogged about here.  This was followed last September with warning letters issued to two Chinese …

    • Schedule III Marijuana Would Still Be Regulated MarijuanaMarch 25th, 2025

      In August 2023, the U.S. Department of Health and Human Services (“HHS”), based on the federal Controlled Substances Act’s (“CSA’s”) Eight Factor Analysis, recommended that the Drug Enforcement Administration (“DEA”) reschedule marijuana from schedule I to schedule III.  The U.S. Department of Justice subsequently conducted …

    • No ACNU Yet; Effective Date Delayed AgainMarch 24th, 2025

      On Friday, March 21, 2025, FDA announced that it was further delaying the effective date for the ACNU final rule until May 27, 2025. We wrote about the December 26, 2024 publication of the final rule (89 FR 105288) here.  Originally, the Nonprescription Drug Product …

    • The Issue with Reissue: PTE EditionMarch 19th, 2025

      Integral to the careful balance Congress struck when passing the Hatch-Waxman Amendments, the patent term extension (PTE) is intended to restore patent life that was consumed during regulatory review of an FDA-regulated product.  Even though the PTE provisions established in the Drug Price Competition and …

    • ACI’s 21st Annual Paragraph IV DisputesMarch 13th, 2025

      The American Conference Institute’s 21st Annual Paragraph IV Disputes is scheduled to take place from April 29-30, 2025 at The Altman Building in New York, NY.  Widely recognized as the industry gold standard, the conference unites leaders from brand-name and generic drug companies, alongside federal judges, the …

    • HPM Director to Moderate at FDLI’s Food and Dietary Supplement Safety and Regulation ConferenceMarch 10th, 2025

      Hyman, Phelps & McNamara, P.C. Director Ricardo Carvajal will be moderating a session at the Food and Drug Law Institute’s (“FDLI’s”) upcoming 1-day conference on Food and Dietary Supplement Safety and Regulation, scheduled to take place on March 25. Join us for timely, in-depth discussions …

    • ACI’s 12th Annual Legal, Regulatory, and Compliance Forum on Cosmetics & Personal CareMarch 10th, 2025

      The American Conference Institute’s 12th Annual Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care is scheduled to take place from March 27-28, 2025, at the New York City Bar Association, New York, NY.  The conference is the premier event on cosmetics and personal care products, …