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# Draft Abbreviated Approval Pathway Guidance
- URL: https://www.fdaweb.com/draft-abbreviated-approval-pathway-guidance/
- Published: 2017-10-12T12:00:00.000Z
- Updated: 2026-09-14T22:55:37.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139853

FDA has issued a draft guidance, *Determining Whether to Submit an ANDA or a 505(b)(2) Application*, to assist applicants to determine which one of the abbreviated approval pathways under the Federal Food, Drug, and Cosmetic Act (FFDCA) is appropriate for the submission of a marketing application to FDA. The [document](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM579751.pdf?ref=fdaweb.com) says that many potential drug product developers are familiar with neither the abbreviated approval pathways described in the law, nor the types of data and information that are permitted to support approval under those pathways.

The guidance highlights criteria for submitting applications under the abbreviated approval pathways described in the law, identifies considerations to help potential applicants determine whether an application would be more appropriately submitted under section 505(j) or pursuant to section 505(b)(2) of the FFDCA, and provides direction to potential applicants on requesting assistance from FDA in making the determination.

The guidance describes standalone NDAs, 505(b)(2) NDAs, ANDAs, and petitioned ANDAs. Contents of the guidance include an Introduction and Background, Abbreviated Approval Pathways, Submission Through Appropriate Abbreviated Approval Pathways, including regulatory and scientific considerations, and Requesting Assistance from FDA.