Yesterday, FDA and the Reagan-Udall Foundation for the FDA convened a public meeting to kick off stakeholder engagement on FDA’s new Rare Disease Framework Initiative. And while there is no shortage of opinions about how FDA should approach rare disease drug development, this time the …
On October 22, 2026, the DOJ Civil Division and the Department of Health and Human Services (HHS) announced a six-month pilot program that offers “legitimate American healthcare businesses” a defined path to come clean on potential False Claims Act (FCA) violations, in exchange for a …
On October 14, 2026, HHS Secretary Robert F. Kennedy, Jr. formally delegated to the CMS Administrator the Secretary’s permissive exclusion authority under Section 1128(b) of the Social Security Act, effective immediately. See Federal Register Notice here. Section 1128(b) allows the government to prohibit companies and …
FDA’s new Rare Disease Framework Initiative is a thoughtful, ambitious, and laudable effort to build a regulatory structure that systematically supports rare disease therapeutic development and review. Detailed in the October 2026 white paper, A New Framework for Rare Disease Review, the initiative is led …
For the third time in this Administration, DOJ is directing its prosecutors to “take an aggressive, all-tools approach to investigating and prosecuting” certain categories of fraud. Unfortunately, the health care and life sciences space has been singled out, and remains solidly in the crosshairs for …
On September 21, 2026, the U.S. District Court for the Northern District of Georgia handed the regenerative medicine industry a significant win, vacating two key FDA determinations regarding MiMedx Group, Inc.’s wound-care product AXIOFILL. The decision, MiMedx Group, Inc. v. FDA, No. 1:24-cv-01287 (N.D. Ga. …
One year after hosting a public workshop (“Advancing the Development of Interchangeable Products: Identifying Future Needs”), and as part of its BSUFA III commitments, FDA, on September 18, 2026, published for comment a strategy document entitled “BsUFA III Future Needs in the Development of Interchangeable …
More than two decades after FDA last publicly grappled with the development of testosterone for women, the Agency is asking industry to take another look. On September 17, 2026, FDA’s Office of Women’s Health (OWH) and the Center for Drug Evaluation and Research (CDER) convened a …
On July 22, 2026, FDA approved Outlook Therapeutics, Inc.’s (“Outlook”) Lytenava (bevacizumab-vikg) for the treatment of neovascular (wet) age-related macular degeneration (“Wet AMD”). This approval was achieved after Outlook’s success through the Formal Dispute Resolution Request (“FDRR”) process following the receipt of multiple Complete Response …
On August 31, 2026, FDA and the Securities and Exchange Commission (SEC) announced a new Memorandum of Understanding (MOU) intended to enhance cooperation between the agencies and facilitate the exchange of non-public information relevant to their respective oversight and enforcement responsibilities. The agreement runs for …
Hyman, Phelps & McNamara, P.C.’s Karla Palmer and Andrew Hull will be speaking again at IQVIA’s 28th Annual Controlled Substance & State Regulatory Conference in Scottsdale, AZ (Sept. 16-18). As part of a stacked agenda that runs the gamut on controlled substances issues, Ms. Palmer will …
For anyone who thought FDA’s Office of Prescription Drug Promotion (OPDP) had lost interest in pre-approval promotion, think again. On August 21, 2026, OPDP issued an Untitled Letter to Alar Pharmaceuticals concerning promotional claims for ALA-3000 injection, an investigational extended-release ketamine product being developed for treatment-resistant …
The American Conference Institute’s (ACI’s) virtual 6th Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA is scheduled to take place from October 20-29, 2026 (Eastern Standard Time). Led by an experienced faculty, the virtual training series is specifically designed for attorneys, regulatory affairs professionals, …
What a year for Hatch-Waxman litigation! With the Supreme Court’s decision in Amarin v. Hikma, it’s already been a big year for the Hatch-Waxman Amendments, but now we have another case from the D.C. Circuit that touches on an important aspect of generic drug incentives: …
FDA recently released a draft guidance titled Container Closure Systems for Human Drugs and Biological Products. The draft supersedes a 1999 guidance and its 2002 Q&A supplement—documents written before the prevalence of container closure systems (CCSs) like pre-filled syringes, metered dose inhalers, and autoinjectors blurred …
