76 New or Revised Product-Specific Guidances Out

FDA has published a batch of 32 new and 44 revised draft product-specific guidances (PSGs) with recommendations for developing generic drugs and generating evidence to support ANDA approvals. An agency post has links to each of the new or revised guidances.

The batch contains 64 PSGs for products with no approved ANDAs, including 27 complex products; 29 PSGs (seven new and 22 revised) for complex products; and PSGs for products to treat non-small cell lung cancer, Parkinson’s disease, chronic myeloid leukemia, brain cancer, and other conditions. One of the PSGs is for adjunct therapy for chronic weight management in adults, citing Lilly’s Zepbound (tirzepatide subcutaneous solution) as the branded drug.

FDA says it also updated its Upcoming PSGs Web page that includes new and revised PSGs under development, with the planned revision categories and brief descriptions of the revisions.