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 …
The American Conference Institute’s (ACI’s) Pharma & Biotech Patent Litigation USA forum is scheduled to take place from October 14-15, 2025 at 3 Times Square in New York, NY. Billed as “the new US Gold Standard event for pharma and biotech patent litigation,” ACI’s Forum …
There are officially signs of life for FDA’s rare pediatric disease priority review voucher (RPD PRV) program! On September 17, the House Committee on Energy and Commerce marked up the Give Kids a Chance Act of 2025 (H.R. 1262), legislation that would reauthorize FDA’s RPD …
FDA’s recent release of 89 Complete Response Letters (“CRLs”) for pending or withdrawn applications (which we blogged about here), and its promise to continue to do so in “real-time” going forward (here), has marked a significant change in FDA policy. Before that, the agency generally …
The American Conference Institute’s (ACI’s) virtual 5th Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA is scheduled to take place from October 14-30, 2025 (Eastern Standard Time). The virtual training series is specifically designed for attorneys, regulatory affairs professionals, and industry executives …
Note: This HPM Fact Sheet, like HHS’s recently issued Fact Sheet, is intended to bring some radical transparency to the discussion around the recently announced DTC Rx drug ad “crackdown.” These bloggers thought it would be helpful to clarify some issues. On September 9, 2025, President …
As an avid reader of OPDP Warning and Untitled Letters that routinely allege pharma companies have engaged in false or misleading Rx drug promotion, this blogger read with interest FDA’s press release on its crackdown on deceptive DTC drug advertising. As I dug into the …
Commissioner Makary’s pronouncement in April of a new pathway for rare disease therapies based on a plausible mechanism of action or biological plausibility generated enormous excitement. The Commissioner’s general statement found meaningful expression in twin announcements this past Wednesday: one by Dr. Tidmarsh of a …
Yesterday, FDA announced the publication of 89 previously unpublished Complete Response Letters (“CRLs”), which appears to be the next step in FDA’s effort towards “radical transparency.” The first step was the posting of 200 already-published CRLs on July 10, 2025, which we blogged about here. …
FDA’s recent approval of Papzimeos (zopapogene imadenovec-drba) highlights FDA’s use of regulatory flexibility in rare, serious diseases with unmet medical need. Approved on August 14, 2025, Papzimeos is the first treatment in the U.S. for recurrent respiratory papillomatosis (RRP), a rare disease characterized by recurrent …
Hyman, Phelps & McNamara, P.C. (HPM) is excited to announce speakers for the program 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. HPM’s Michelle …
As the summer of 2025 comes to a close and we begin to look toward to the 2026 Fiscal Year, FDA is completing its reporting on 2024. The FDA’s fiscal year 2024 Report on the State of Pharmaceutical Quality from CDER’s Office of Pharmaceutical Quality …
