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# NDA, BLA Refuse-to-File Guidance
- URL: https://www.fdaweb.com/nda-bla-refuse-to-file-guidance/
- Published: 2017-12-12T12:00:00.000Z
- Updated: 2026-09-14T23:07:38.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140323

FDA has issued a draft guidance, *Refuse to File: NDA and BLA Submissions to CDER*, to clarify circumstances under which CDER may refuse to file new or supplemental NDAs and BLAs for therapeutic products regulated by the Center. The [guidance](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM588242.pdf?ref=fdaweb.com) also is to underscore the importance of submitting a complete application to minimize the chance of a refuse-to-file action by FDA, it says.

In particular the guidance focuses on agency policy for refusing to file an NDA under Section 314.101(d)(3) when the NDA is incomplete because it does not on its face contain information required under Section 505(b) of the Federal Food, Drug, and Cosmetic Act and associated regulations. It does not address scenarios in which an application is incomplete for other reasons.

The agency says it has committed to timely review of applications under PDUFA and the overall goal is to efficiently and effectively review applications. Thus, it says, it is critical to avoid using resources to review an application when necessary components are so facially deficient as to render them incomplete.

“FDA exercises its refusal-to-file authority for incomplete applications to optimize the use of both the applicant’s and FDA’s resources,” the guidance says. “Refusal-to-file actions allow FDA to notify applicants of application deficiencies as soon as possible, rather than waiting until the end of a review cycle and notifying the applicant in a complete response letter. This process can lead to more rapid approval of safe and effective drug and biological products.”