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

    • Kessler Petition Seeks Revocation of GRAS Status for Processed Refined CarbohydratesAugust 13th, 2025

      News coverage of the citizen petition submitted by Dr. David Kessler has been somewhat breathless, so it was nice to read the document first hand when it was posted yesterday in the docket at regulations.gov – and you should do the same. Spoiler alert! In …

    • MDUFA VI Reauthorization Public Meeting Hears Many Perspectives on Device User FeesAugust 12th, 2025

      On August 4, 2025, FDA hosted a public meeting related to the reauthorization of the Medical Device User Fee Act for fiscal years 2028 through 2032 (MDUFA VI).  The FDA invited public comment on the following questions and most speakers remarks provided perspectives related to …

    • Demand Forecasting for Controlled Substances Public MeetingAugust 12th, 2025

      Hyman, Phelps & McNamara, P.C.’s John Gilbert will be speaking at the Demand Forecasting for Controlled Substances Hybrid Public Meeting sponsored by the Reagan-Udall Foundation for the FDA, Washington, DC. on August 27, 2025. The meeting is from 2-5pm (eastern) and includes both in-person and …

    • FDA Formally Rescinds the LDT Final Rule Following Defeat in CourtAugust 11th, 2025

      On August 6, 2025, the Office of Information and Regulatory Affairs (OIRA) published a notice that FDA has rescinded the Laboratory Developed Test (LDT) Final Rule that was vacated earlier this year by the U.S. District Court for the Eastern District of Texas. The rescission …

    • Silicon Valley Life Sciences DayAugust 7th, 2025

      Hyman, Phelps & McNamara, P.C. (HPM) is excited to announce a program that we are co-hosting with Freshfields geared toward early-stage biotech and medtech companies. This program will be a half-day, in-person event at Freshfields’ Silicon Valley office on Wednesday September 10, 2025, and will feature …

    • Leading the Way: Highlights from the 12th Annual ACI Women Leaders in Life Sciences Law SummitAugust 6th, 2025

      Boston was once again the hub for female leadership in life sciences law this summer as attorneys, executives, and policymakers gathered for the 12th Annual American Conference Institute (“ACI”) Women Leaders in Life Sciences Law Summit on July 30–31, 2025. Hosted at the Seaport Hotel, the …

    • Federal Court Declares FDA’s Civil Monetary Penalty Provisions For Tobacco Products UnconstitutionalAugust 5th, 2025

      Late last week, the U.S. District Court for the Northern District of Texas ruled that FDA’s civil monetary penalty (CMP) provision for tobacco products contained at 21 U.S.C. § 333(f)(9) is unconstitutional.  Relying on the Supreme Court’s recent decision in SEC v. Jarkesy, 603 U.S. 109 …

    • Defining “Ultra-Processed” Food: FDA Wants Your InputAugust 4th, 2025

      Since 2009, the term ultra-processed food (“UPF”) has gained recognition as there have been studies that suggest a relationship between consumption of UPFs and chronic diseases.  The term frequently focuses on processing and composition without consideration of food groups and nutritional composition.  At this time, …

    • Court Decision Dilutes Hopes of Homeopathic Industry for New Regulatory PathwaysAugust 1st, 2025

      One familiar with homeopathy might reasonably think that the practice would have a place in the Make America Healthy Again movement as an alternative to conventional pharmaceutical treatment. But after a recent court decision issued on July 15, 2025, the regulatory path for homeopathic medicine …

    • A Tip of the Hat to Retiring DEA Chief ALJ MulrooneyJuly 31st, 2025

      Earlier this week, we posted on the retirement of DEA Chief Administrative Law Judge Judge John J. Mulrooney, II, and the lack of appointed DEA ALJs to hear DEA cases upon his retirement, effective August 1.  On a related note, HPM wants to take a …

    • A Software Demo is Worth a Submission Full of Screenshots, But Is An Early Orientation Meeting Worth the Time?July 30th, 2025

      On July 24, 2025, FDA released the Regulatory Accelerator, an initiative to help digital health sponsors bring their technology to market. New developers may want to bookmark this link as the initiative neatly corrals information in one place. For those who have been working in …

    • FDA’s Latest Lists for Digital Health TechnologiesJuly 29th, 2025

      FDA announced earlier this month that it had updated its list of artificial intelligence (AI)-enabled medical devices and created new lists for medical devices that incorporate augmented reality or virtual reality and medical devices that incorporate sensor-based digital health technology.  The list for AI-enabled devices …

    • Oyez, Oyez, Oyez! Effective August 1, DEA Will Have No Administrative Law JudgesJuly 28th, 2025

      Last week, DEA registrants and applicants with pending actions before DEA’s Office of Administrative Law Judges (OALJ) received an order from Chief Administrative Law Judge John J. Mulrooney, II, staying the hearing proceedings in those cases.  In those orders, Chief Judge Mulrooney announced that he …

    • Whose 510(k) Is It Anyway?July 25th, 2025

      FDA recently released a draft guidance regarding the transfer or sale of a 510(k) clearance. When a 510(k) for a device is sold or transferred from one entity to another, the new 510(k) holder must list the device with the FDA.  If the device has …

    • Color Food Beautiful: FDA Approves Gardenia Blue and Continues Push to Phase OutJuly 24th, 2025

      On July 14, 2025, the U.S. Food and Drug Administration (FDA) approved Gardenia Blue, a plant-based color additive, while simultaneously making clear to industry that the Agency encourages food manufacturers to accelerate their phasing out of the use of the synthetic dye FD&C Red No. …