The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Refuse to File: NDA and BLA Submissions to CDER.'' The purpose of this guidance is to clarify certain circumstances under which FDA's Center for Drug Evaluation and Research (CDER) may refuse to file a new drug application (NDA) or supplemental NDA, or a biologics license application (BLA) or supplemental BLA submitted to CDER, and to underscore the importance of submitting a complete application to minimize the chance of a refuse- to-file (RTF) action by FDA.
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Refuse To File: New Drug Application and Biologics License Application Submissions to the Center for Drug Evaluation and Research; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Refuse to File: NDA and BLA Submissions to CDER.'' Th...
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82 FR 58615
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“Refuse To File: New Drug Application and Biologics License Application Submissions to the Center for Drug Evaluation and Research; Draft Guidance for Industry; Availability,” thefederalregister.org (December 13, 2017), https://thefederalregister.org/documents/2017-26791/refuse-to-file-new-drug-application-and-biologics-license-application-submissions-to-the-center-for-drug-evaluation-and-.