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# Guide on ANDA Prior Approval Supplements
- URL: https://www.fdaweb.com/guide-on-anda-prior-approval-supplements/
- Published: 2022-10-14T12:00:00.000Z
- Updated: 2026-09-14T18:03:16.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152973

FDA has released a [final guidance](https://www.fda.gov/media/89263/download?ref=fdaweb.com) entitled “ANDA Submissions – Prior Approval Supplements (PAS) Under GDUFA.” The document explains how the recently reauthorized generic drug user fee program relates to PAS submissions. It also incorporates performance goals currently outlined in the reauthorization. Specifically, the guidance describes how the user fee performance goals apply to:

- A PAS subject to the refuse-to-receive standards
- A PAS that requires an inspection
- A PAS for which an inspection is not required
- An amendment to a PAS
- Other PAS-related matters