FDA recently published draft guidance explaining how medical gas manufacturers should comply with new regulations that become effective today, December 18, 2025. As an early gift for the holidays, the industry is getting its own set of Current Good Manufacturing Practices (cGMPs). These cGMPs were …
Priority Review Vouchers (PRV) are incredibly valuable—several have sold for hundreds of millions of dollars. Which is why it makes sense that Sun Pharma Advanced Research Co. Ltd. and Sun Pharmaceutical Industries, Inc. went to the mat fighting FDA for a PRV for phenobarbital. And …
Hyman, Phelps & McNamara, P.C. (HPM) is excited to announce that Fabiola Cervantes-Gomez, Ph.D. has joined the firm as a CMC Regulatory Expert. Dr. Cervantes-Gomez brings over eight years of experience from the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER), …
FDA is moving with notable speed. Less than a month after announcing its inaugural class of Commissioner’s National Priority Voucher (CNPV) winners (see our previous post), the agency has already named its second cohort. The CNPV program, designed to accelerate the review of products that advance …
On November 6, 2025, the Centers for Medicare & Medicaid Services (CMS), through its Center for Medicare and Medicaid Innovation, announced the upcoming launch of the voluntary GENEROUS (GENErating cost Reductions fOr U.S. Medicaid) model, through which participating drug manufacturers can offer “most favored nation” …
Last Friday, October 31, the Centers for Medicare & Medicaid Services (CMS) released the Calendar Year (CY) 2026 Medicare Physician Fee Schedule (PFS) Final Rule, which contained important changes in regulations governing the calculation of average sales price (ASP) for drugs covered under Medicare Part …
Biosimilars, costing about 50% of their reference products, have generated $56 billion in healthcare savings since 2015, with $20 billion saved in 2024 alone. Compared to the small molecule market though, that’s pocket change. It should come as no surprise therefore that FDA is actively …
On September 30, 2025, FDA held a public meeting titled “Onshoring Manufacturing of Drugs & Biological Products.” Driven by Executive Order 14293, “Regulatory Relief To Promote Domestic Production of Critical Medicines,” the meeting focused on reducing U.S. dependence on foreign pharmaceutical sources and promoting investment …
FDA recently released a draft guidance, titled “Postapproval Methods to Capture Safety and Efficacy Data for Cell and Gene Therapy Products,” that provides valuable direction and insight into how sponsors can (and should) approach long-term data collection once a cell and gene therapy (CGT) product …
We previously blogged about the Commissioner’s National Priority Voucher (CNPV), FDA’s new pilot program to expedite the reviews of selected programs that meet certain national priorities. As a reminder, these national priorities were described as including (but not limited to): Addressing a U.S. public health crisis Delivering …
On October 9, 2025, the U.S. Senate voted in favor of including a revised version of the BIOSECURE Act as an amendment to the National Defense Authorization Act (NDAA). The bill was not included in the version of the NDAA passed by the U.S. House …
As part of the review of a BLA, NDA, or ANDA, FDA assesses the manufacturing facilities named in the application to determine whether they can perform the proposed manufacturing operations in conformance with CGMP requirements, and whether the data submitted in the application are accurate …
FDA has long permitted ANDA applicants to “carve-out” patent-protected uses from product labeling, resulting in differences between the Reference Listed Drug and the ANDA. Legal challenges to the carve-out are not new: The GSK v. Teva saga, followed by the Amarin v. Hikma litigation, made …
On September 11, 2025, Reps. Diana Harshbarger (R-TN) and Buddy Carter (R-GA)—the only two pharmacists in the U.S. House of Representatives—introduced a new bill, titled “Drug Shortage Compounding Patient Access Act” (H.R. 5316), that would expand the ability of compounding pharmacies and outsourcing facilities to …
FDA’s September 22, 2025 News Release and announcement in a prepublication Federal Register notice (to be published on September 24, 2025) that GlaxoSmithKline’s (“GSK’s”) Wellcovorin (leucovorin calcium) Tablets, EQ 5 mg base and EQ 25 mg base, which was approved under NDA 018342 (initially approved …
