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 products. As of March 8, 2026, the Agency reports that the OGD has issued 2,407 PSGs (see post here). While it isn’t necessary to follow the FDA’s advice, it’s certainly a great strategy for predicting a clear path to approval.
Guidances are first issued in draft, and the FDA welcomes comments on the drafts. While the Agency’s official position is that draft guidances are not to be implemented, it would be foolish not to treat the draft PSGs as the FDA’s current expectations regarding bioequivalence for these products. As the FDA notes, a guidance “does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.”
The issuance of revised PSGs may, at times, present potential problems for generic applicants in that they may change the bioequivalence expectations for already-approved applications or impact applications in development for which firms have already completed BE studies under recommendations in the original PSGs or submitted ANDAs containing studies that relied on previous PSGs. In addition, when the FDA issues new PSGs for products for which no advice had previously been issued, it could also impact the work that generic companies have already undertaken for applications when the PSGs contain different approaches than taken by the firms. Under GDUFA III, the FDA opened lines of communication for such situations by permitting either telcons or meetings when firms find that they need advice after new or revised PSGs are issued.
There has been some talk about the FDA redlining revised PSGs to make it easier for firms to better identify specific changes. While we’ve been suggesting such changes for years, maybe now, in the not-too-distant future, the OGD will begin doing this very thing. It would certainly make life easier for sponsors seeking the FDA’s advice on bioequivalence requirements. After all, when a firm makes a change in an SOP, there is required to be an accompanying change-control section in the document outlining the change. Shouldn’t FDA-issued PSGs also abide by this requirement?
So, check out the new listings and take appropriate action, depending on your firm’s individual circumstances and portfolio. If you need advice on the applicability of these PSGs to your firm’s products, Lachman can help! Reach out to us at LCS@LachmanConsultants.com.
