Sameness Evaluations in an ANDA — Active Ingredients

8 November 2022 – FDA published draft guidance on sameness evaluations in an ANDA. Submit comments by 8 January 2023.

This guidance is intended to assist applicants preparing an abbreviated new drug application (ANDA) by providing recommendations on demonstrating sameness between the active ingredient in a proposed generic drug product and its reference listed drug (RLD) as required under section 505(j)(2)(A)(ii) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)(2)(A)(ii)) and FDA’s regulations in § 314.94(a)(5) (21 CFR 314.94(a)(5)).