> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Prior Approval Supplement Submission Guidance
- URL: https://www.fdaweb.com/prior-approval-supplement-submission-guidance/
- Published: 2017-10-04T12:00:00.000Z
- Updated: 2026-09-14T22:54:09.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139779

FDA has issued a guidance, *ANDA Submissions—Prior Approval Supplements*, to assist applicants preparing to submit to FDA prior approval supplements (PASs) and amendments to PASs for ANDAs. The [document](http://s2027422842.t.en25.com/e/er?s=2027422842&lid=392&elqTrackId=5B0C77B37F7276A73BDD2A9A394BFE8B&elq=60705f28ce024457ad7873a71302ce25&elqaid=757&elqat=1&ref=fdaweb.com) explains how GDUFA relates to PAS submissions and describes the performance metric goals outlined in the GDUFA 1 and 2 authorization documents. Specifically, the guidance describes how the GDUFA performance metric 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, and other PAS-related matters.