Health Law Daily Wrap Up, ADMINISTRATION OF FDC ACT—FDA GUIDANCE NOTICES: Determining Whether To Submit an ANDA or a 505(b)(2) Application; Draft Guidance for Industry; Availability, (Aug 18, 2026)

By WK Editorial Staff

The FDA is announcing the availability of a draft guidance for industry titled "Determining Whether to Submit an ANDA or a 505(b)(2) Application."

This draft guidance is intended to serve as a foundational guidance to assist applicants in determining which one of the abbreviated approval pathways under the Federal Food, Drug, and Cosmetic Act (FDC Act) is appropriate for the submission of a marketing application to FDA. This draft guidance revises the guidance for industry titled ‘‘Determining Whether to Submit an ANDA or a 505(b)(2) Application’’ issued in May 2019 and, when finalized, will replace the 2019 guidance for industry (FDA Guidance Notice, 91 Fed. Reg. 53418 (Aug. 18, 2026)).

Dates. Submit either electronic or written comments on the draft guidance by October 19, 2026, to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.

FederalRegisterIssuances: FDAGuidanceNotices FDCActNews DrugBiologicNews