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 actual guidance documents has occurred, despite the shutdown.
Usually when the FR notice announces new PSGs, they appear right away on the FDA website (here) but an initial search for the new documents suggested that the government shutdown may have delayed their publication. However, we checked again about an hour later and are happy to let you know that the PSGs have now been published. These guidance documents are not only exceedingly important for ongoing generic drug development but could mean that sponsors may see some downregulation in previous bioequivalence requirements or they may need to make changes in their bioequivalence study designs. Without this information readily available, generic drug developers might have been missing key information regarding the FDA’s current thinking on bioequivalence requirements for at least the 75 products cited in the October 1, 2025 FR notice. We’re glad to see that the PSGs have been published as this will certainly put generic sponsors in favorable position to avoid going down wrong bioequivalence development pathways, resulting in delays of potential generic product approvals.
Luckily, timely publication of the PSGs has avoided one of many problems that the FDA and industry will face in the coming days or weeks unless our elected officials find a way to resolve their differences and reopen the U.S. government.
