New and Revised PSGs – Time to Check Your Portfolio!

Yesterday, the FDA announced the issuance of 14 new product-specific guidances (PSGs) and 54 revised guidances that provide the FDA’s current thinking on the requirements for bioequivalence testing for generic drugs (here).  In addition, the FDA updated its list of planned PSG issuances (73 new PSGs) as well as the list of PSGs that it is planning to revise over the next year (46 PSGs) (here).  This represents not only a lot of new PSGs that you must take into consideration but also entails a significant number of PSG revisions that could impact your current portfolio.  This may pose problems for firms that already have any of these products in development, currently undergoing biostudies or with biostudies completed, or have applications about to be filed or already filed for any of the products on these lists.

On August 19, 2024, the OGD released a final guidance titled Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA.  We published a blog on that same date (here) to outline the intent of the guidance and how the FDA anticipates that firms will deal with the issuance of new PSGs or revisions to PSGs under the specific circumstances described above.  While many of the published revisions of PSGs or those that are planned may be minor in nature, it behooves applicants to take a proactive approach to reviewing the published revised guidances as well as the updated list of guidances that are planned for revision over the next year to see how they may impact your drug development programs and pipeline; if you see any potential problems, you should have ample time to discuss the issues with the FDA.

For years, the revision of guidances or the publication of new guidances has troubled firms that already have applications in house or under development, and, in some cases, the revisions or issuances have required extensive additional work for ANDA applicants in order to prepare for ANDA submission or amend an application that has already been submitted.  With the issuance of Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA: Guidance for Industry, the FDA has indicated how firms can interact with the Agency to help resolve any issues related to new or revised PSGs.  So, please, do your due diligence by carefully reviewing the new and revised PSGs as well as those that are planned for issuance in the coming year—and make early contact with the OGD.  Don’t wait to be surprised!