The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry titled "Determining Whether to Submit an ANDA or a 505(b)(2) Application." This draft guidance is intended to serve as a foundational guidance to assist applicants in determining which one of the abbreviated approval pathways under the Federal Food,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 (FD&C 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 This draft guidance revises the guidance for industry titled "Determining Whether to Submit an ANDA or a 505(b)(2) Application" issued in May 2019 and, when finalized, will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.
US Federal Register - FDA Guidance Notices · August 18, 2026
Determining Whether To Submit an ANDA or a 505(b)(2) Application; Draft Guidance for Industry
Original title: Determining Whether To Submit an ANDA or a 505(b)(2) Application; Draft Guidance for Industry; Availability
FDA announces draft guidance revising 2019 guidance on choosing between abbreviated and 505(b)(2) approval pathways for marketing applications.
Published by US Federal Register - FDA Guidance Notices. HealthSignal links to the original document; the summary above is extracted from the source text.