FDA Issues New Batch of Product-Specific Bioequivalence Guidances for Generics

The FDA issued its latest batch of product-specific guidances for generic drugs, including 34 new guidances and 19 revised drafts.

The guidances set out the agency’s current thinking on product-specific designs for bioequivalence studies to support ANDAs.

The agency aims to make the process for copying the generics more efficient and to create an easier path for generic alternatives to enter the market. The online database now includes 1,760 currently published product-specific guidances.