FDA Releases Recommendations On Bioequivalence Studies for ANDAs

In a Jan. 25 notice, the Food and Drug Administration announced availability of additional draft and revised draft product-specific bioequivalence (BE) recommendations (77 Fed. Reg. 3777).

FDA said the recommendations provide product-specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs) for generic drugs.

FDA said the BE recommendations identified in this notice were developed using the process described in a guidance document from 2007. The Federal Food, Drug, and Cosmetic Act and FDA’s rules require that an ANDA applicant submit, among other things, information showing that the applicant’s drug product is ...