It is no small task to get a guidance document issued by the FDA in normal operating times but in the face of the longest government shutdown in history, the issuance of 76 PSGs (32 new and 44 revised) is nothing short of amazing. Yesterday, the FDA announced the new and revised guidance documents’ availability […]
ANDAs are complicated submissions that involve a lot of data, explanations, and clear and concise statements. There is often also an associated rush to meet a deadline for ANDA submission that has the potential to create errors, either by omitting important data or not providing sufficient clarity in the submission. At the AAM GRx+Biosims meeting […]
From a historical perspective, I can’t remember when the turmoil at the FDA was greater, nor can I remember when the morale was lower with perhaps the exception of while the generic drug scandal of the late 80s was occurring. However, despite all the turmoil and the distractions, the Office of Generic Drugs (OGD) has […]
With a new U.S. administration and leadership at HHS, regulatory priorities have evolved over the course of 2025. While the exact current and potential future priorities of the FDA may not be fully known at this point, one can expect continued focus on compliance, product quality, and supply-chain resilience, making it crucial for pharmaceutical and […]
On day two of AAM’s October meeting, a panel including Jim Polli, Ph.D., Professor at the University of Maryland, Anna Scwenderman, Ph.D., Professor at the University of Michigan College of Pharmacy, and Aaron Josephson, Senior Director at Teva Pharmaceuticals, discussed the International Generic and Biosimilar Medicines Association’s (IGBA) project update on Single Global Development for […]
The AAM GRx+Biosims meeting was in progress when word came down that, within minutes, a new guidance document would be released by the FDA to outline conditions under which comparative efficacy studies (CES) may not be required for biosimilar applications. The draft Guidance for Industry (here) is titled Scientific Considerations in Demonstrating Biosimilarity to a […]
The AAM GRx+Biosims meeting recently concluded, and it was great to see so many familiar faces and to meet individuals in person for the first time. This conference always affords attendees opportunities to hear new insights from FDA leadership and catch up with colleagues. I’m sure that attendees all had a favorite session or discussion, […]
As I was sitting at the AAM’s GRx-Biosims meeting this week listening to the presentation from Dr. Iilun Murphy, Director of the Office of Generic Drugs, I clicked on a link on my computer for the Generic Drugs Program Monthly and Quarterly Activities Report and noticed that the report had been just updated with the […]
As we near the end of October 2025, the first month of new FY 2026, and as FDA appropriations languish in our dysfunctional Congress, the number of fee-paying submissions submitted to FDA so far in the new Fiscal Year 2026 = 0. That’s right nada, nil, zero, zilch, none. You can count the number on […]
Elizabeth Miller, Associate Commissioner for Inspections and Investigations, provided an update on the FDA’s Office of Inspections and Investigations (OII). She noted that the government shutdown has impacted the OII’s core activities which include inspections, investigations and imports. She noted that the lapse in appropriations has resulted in the need for risk-based prioritization of OII’s […]
