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# Guidance on ANDA Refuse-to-Receive Standards
- URL: https://www.fdaweb.com/guidance-on-anda-refuse-to-receive-standards/
- Published: 2017-01-03T12:00:00.000Z
- Updated: 2026-09-14T21:57:42.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137622

FDA has released a [guidance](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM370352.pdf?ref=fdaweb.com) on “ANDA Submissions – Refuse-to-Receive Standards” that is intended to assist applicants preparing to submit ANDAs and prior approval supplements for which the applicant is seeking approval of a new strength of the drug product. The document highlights deficiencies that may cause the agency to refuse to receive an ANDA, which means the submission is not substantially complete.