Hyman, Phelps & McNamara, P.C. (HP&M), is pleased to announce that Director Anne Walsh will be speaking at the DIA Advertising and Promotion Regulatory Affairs Conference. This essential event for regulatory professionals in the biopharmaceutical and medical device industries will take place March 12-13, 2024, …
FDA’s proposed rule to regulate laboratory developed tests (LDTs) as devices took one more step towards publication as a final rule – and to a likely judicial showdown. On March 1, the Office of Management and Budget (OMB) received the draft final LDT rule for …
The most recent version of the BIOSECURE Act (the “Act”) was introduced in the U.S. House of Representatives (H.B. 7085) and Senate (S.B. 3558) on January 25, 2024. This proposed legislation should be of interest to any biotechnology companies that want to do business with …
Earlier this week, we posted Part 1 of our three-part series on U.S. Patent and Trademark Office (“PTO”) Patent Term Extension (“PTE”) decisions under 35 U.S.C. § 156, as added by the 1984 Hatch-Waxman Amendments, for certain FDA-regulated products. Part 1 focused on both the …
On Friday, February 23, 2024, FDA announced its final decision to withdraw the approval of Pepaxto (melphalan flufenamide), which was approved in February 2021 in combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at …
It’s been a while since we last blogged on Patent Term Extension (“PTE”) issues of interest. And with 2024 (September 24th) being the 40th anniversary of the enactment of the 1984 Hatch-Waxman Amendments—the statute that amended Title 35 of the United States Code to create …
Hyman, Phelps & McNamara, P.C. (HP&M) proudly announces that Director Anne Walsh will be a featured panelist at the highly anticipated 2024 Women’s White Collar Defense Association (WWCDA®) Leadership Retreat and Annual Attorney Meeting. The event is set to take place from March 4-6, 2024, …
While the Biologics Price Competition and Innovation Act (“BPCIA”) is inherently distinct from the Hatch-Waxman Act, many of the fundamental concepts FDA adopted as it enacted the Hatch-Waxman Act made their way into FDA’s implementation of the BPCIA. This of course, make sense—after decades of …
More than five years after FDA first announced its plan to harmonize 21 CFR Part 820 with ISO 13485, on February 2, 2024, FDA finally issued the Quality Management System Regulation (QMSR) Final Rule. The final rule emphasizes risk management activities and risk-based decision making. …
On Feb. 2, 2024, FDA’s Center for Veterinary Medicine (CVM) announced that it will withdraw its Program Policy and Procedures Manual Guide 1240.3605 (PPM). As readers of this blog may recall, this PPM dates from 1998. It reflects CVM’s narrow interpretation of what constitutes a …
Hyman, Phelps & McNamara, P.C. (“HP&M”) is pleased to announce that Ana Loloei has joined the firm as Counsel. Ms. Loloei is a 14-year veteran of the FDA, where most recently she served as a Senior Regulatory Counsel in the Office of Policy at CDRH. …
With apologies to David Letterman, who introduced the first Top Ten List on Late Night with David Letterman on September 18, 1985, we present “Marijuana: Top Ten Reasons for Descheduling, Rescheduling or Not.”* The wide range of assertions supporting or opposing Health and Human Services’ (“HHS’”) …
As an end of the year gift, FDA finalized its guidance document, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations, in late December. We previously blogged on the draft guidance (here) and on FDA’s broader framework for Digital Health Technologies (DHT) (here and …
Last week, DEA and DOJ announced a $59 million civil penalty settlement with eBay related to the failure to comply with Controlled Substances Act (CSA) requirements for identifying purchasers, maintaining records, and filing reports of individuals selling/purchasing pill presses and encapsulating machines. As stated in …
The House Committee on Energy and Commerce Subcommittee on Oversight and Investigations invited Hyman, Phelps & McNamara, P.C. Counsel John Claud to testify yesterday about FDA’s foreign inspection program. Mr. Claud frequently counsels foreign and domestic clients on issues relating to inspections and cGMP remediations. We’ve …
