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# ANDA vs. 505(b)(2) Determination Guidance
- URL: https://www.fdaweb.com/anda-vs-505-b-2-determination-guidance/
- Published: 2019-05-09T12:00:00.000Z
- Updated: 2026-09-15T01:25:46.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144073

FDA has published a guidance, *Determining Whether to Submit an ANDA or a 505(b)(2) Application*, to help applicants determine which of the abbreviated approval pathways is appropriate for submission of a marketing application to the agency. The [document](https://www.fda.gov/media/124848/download?utm%5Fcampaign=FDA%20issues%20Final%20Guidance%20for%20Industry%20on%20Determining%20Whether%20to%20Submit%20an&utm%5Fmedium=email&utm%5Fsource=Eloqua) says that many potential drug product developers are not familiar with the different abbreviated approval pathways or the types of data and information that are permitted to support approval under the pathways.

“To familiarize potential drug product developers with these abbreviated pathways, this guidance highlights criteria for submitting applications under the abbreviated approval pathways described in Section 505(j) and 505(b)(2), identifies considerations to help potential applicants determine whether an application would be more appropriately submitted under Section 505(j) of the Federal Food, Drug, and Cosmetic Act, and provides direction to potential applicants on requesting assistance from FDA in making this determination,” the guidance says.