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 […]
With the addition of the six new vouchers awarded today, the total number of CNPVs awarded is fifteen. It’s interesting to note that Dr. George Tidmarsh, the short-time CDER Director, was reported to have been critical of the CNPV program, worried that the compressed one to two month review and approval times would compromise safety and […]
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 […]
Digital resilience is a concept that often needs to be revised and redefined within an organization. The pharmaceutical industry can be slow at times to identify potential external risks and assess the potential impact to operations. Much of the work we do here at Lachman helps regulated industry anticipate and mitigate Quality Management System risks […]
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 […]
