FDA Publishes 32 New Product-Specific Guidances

FDA has published 32 new product-specific guidances (PSGs) with recommendations for developing generic drugs and generating evidence to support ANDA approvals. The new PSGs include 26 new documents, with 10 for new chemical entities, and six revised guidances. Some 25 of the new PSGs are for products with no ANDAs, including 11 complex products. There are 13 (eight new and five revised) PSGs for complex products.

The agency also updated its Upcoming Product-Specific Guidances for Generic Drug Product Development Web page, which includes new and revised PSGs under development with the planned revision categories and brief descriptions of the revisions.

The 32 new PSGs include a new guidance for overdose treatment nalmefene HCl nasal spray (Indivior’s Opvee), a new PSG for cystic fibrosis tobramycin inhalation powder (Viatris’ Tobi Podhaler), and a revised PSG for acne treatment tretinoin topical gel.