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# FDA Guide on ANDA Prior Approval Supplements
- URL: https://www.fdaweb.com/fda-guide-on-anda-prior-approval-supplements/
- Published: 2016-10-14T12:00:00.000Z
- Updated: 2026-09-14T21:39:40.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137079

FDA has released a [guidance ](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM404441.pdf?ref=fdaweb.com)on “ANDA Submissions — Prior Approval Supplements Under GDUFA” that is intended to assist applicants preparing such submissions. The document describes the agency’s performance metric goals for reviewing these and clarifies how it will handle submissions that fall under user fee performance metric goals.