FDA Issues 81 Product-Specific Bioequivalence Guidances for API Generics

The FDA issued its latest batch of product-specific guidances for generic drugs, including 28 new and 53 revised guidances.

When finalized, the guidances will reflect the agency’s current thinking on the product-specific design of bioequivalence studies to support ANDAs for APIs such as testosterone and lovastatin.

Most of the new draft guidances are aimed at oral formulations of products, while most of the revised guidances are aimed at topical and transdermal formulations.