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 […]
The OGD posted 29 new and 31 revised product-specific guidances (PSGs) today (see here). The new list of PSGs covers drugs with various dosage forms including tablets, capsules, gels, oral suspensions, intramuscular extended-release suspensions, topical solutions, powders, ointments, other parenteral products and orally disintegrating tablets, and subcutaneous extended-release suspensions. One of the new PGSs for […]
A pre-publication Federal Register notice today (here) announced the first group of product-specific guidances (PSGs) for which the requirement for a fed, in-vivo bioequivalence (BE) study has been removed. In some instances, the fasting, in vivo bioequivalence requirements were modified such that now only one in vivo study will be required to support a bioequivalence […]
On September 20, 2024, we posted a blog on the changes that are being contemplated by the FDA with issuance of the final M13A guidance (here). One of the major changes delineated in this guidance was elimination of the previous requirements for fed bioequivalence studies in over 850 different Product Specific Guidances (PSGs) for solid oral […]
Today, the FDA released a final guidance titled Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA (here). Wading through the 26-page document is a bit of a chore, but there is a lot of useful information that will provide applicants with advice on what to do, when to do it, and how to […]
