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# FDA Draft Guide on NDA/BLA Refuse to File Actions
- URL: https://www.fdaweb.com/fda-draft-guide-on-nda-bla-refuse-to-file-actions/
- Published: 2017-12-13T12:00:00.000Z
- Updated: 2026-09-14T23:08:12.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5140337

*Federal Register* notice: FDA has made available a draft guidance entitled “Refuse to File: NDA and BLA Submissions to CDER” that is intended to clarify certain circumstances under which the Center may refuse to file an application. It also addresses the importance of submitting a complete application to minimize any review delays. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2017-12-13/pdf/2017-26791.pdf?ref=fdaweb.com).