Today, the FDA published 55 product specific guidances (PSGs) that provide FDA’s current bioequivalence recommendations for generic products. The PSGs can be found here and the current listing represents 24 new and 31 revised PSGs. FDA says that today’s batch of 55 PSGs contain: More than 30 for products with no approved ANDAs including 15 […]
With four and a half months remaining in fiscal year 2026, the Center for Drug Evaluation and Research (CDER) has published the list of 85 new or revised guidance documents that it plans to release this year! The document (here) categories along with the number of anticipated guidances are as follows: Administrative/Procedural – 8 Artificial […]
In this morning’s Federal Register pre-notification page (here), the FDA announced the addition of 23 new Product-Specific Guidances (PSGs) and 48 revised PSG documents. The FDA began publishing PSGs on June 11, 2010 when it announced its first group of PSGs to assist firms in understanding the FDA’s current thinking on the bioequivalence requirements for specific […]
Today, the FDA issued 44 new and 37 revised draft product specific guidances (PSGs) outlining FDA’s current thinking on the requirements for establishing bioequivalence to reference listed drugs or reference standards. None of the guidance documents were finalized in the current listings. According to the FDA Email, the 81 guidance documents included (and yes, I […]
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 […]
Dr. Iilun Murphy, Director of the Office of Generic Drugs presented on the State of OGD. Some interesting numbers presented include the fact that OGD received only 600 new ANDAs in FY 2025. She acknowledged that the pace of ANDA submissions was way down (from 740 in FY 2024). OGD on the other hand approved […]
In today’s pre-publication Federal Register notice (here), the FDA announced publication of 17 new product specific guidances (PSGs) and 58 revised PSGs. This is the first release of PSGs since the May 20, 2025 dump of 36 new and 15 revised PSGs. Not only is this good news for developers of generic drugs, release of the […]
According to an article in the Pink Sheet (here, subscription required) authored by Sarah Karlin-Smith, some policy staff are returning to work at the Center for Drug Evaluation and Research. Hopefully that means that we will see more timely work on product-specific guidances (PSGs), informational postings, and statistical reporting from the Agency. In the Office […]
We mentioned the delay in publication of OGD statistics a couple of days ago in our post here. There has also been a delay, caused by the reduction in force at the OGD, of the publication of quarterly product-specific guidance documents (PSGs), but now the wait is over! According to the FDA announcement here, “[t]oday’s […]
There is a hint that the “pause” or freeze on communications from the FDA may be starting to thaw. This morning, a CDER Small Business and Industry Assistance (SBIA) Webinar titled Navigating Controlled Correspondences to Support Generic Drug Development, to be held on February 27, 2025 from 1:00 to 3:30 p.m., was posted with a request […]
