Health Law Daily Wrap Up, DRUGS AND BIOLOGICS—FDA GUIDANCE NOTICES: Draft guidances provide product-specific recommendations, (May 20, 2024)

By WK Editorial Staff

The FDA announced the availability of additional draft and revised draft product-specific guidances.

The draft guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, the FDA announced the availability of a guidance for industry entitled ‘‘Bioequivalence Recommendations for Specific Products’’ that explained the process that would be used to make product-specific guidances available to the public on the FDA’s website. The draft guidances identified in the notice were developed using the process described in that guidance (Notice, 89 Fed. Reg. 43413 (May 17, 2024)).

Dates. Submit either electronic or written comments on the draft guidance by July 16, 2024.

FederalRegisterIssuances: FDAGuidanceNotices FDCActNews DrugBiologicNews PrescriptionDrugNews