federal_register: 2017-26791
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2017-26791 | Refuse To File: New Drug Application and Biologics License Application Submissions to the Center for Drug Evaluation and Research; Draft Guidance for Industry; Availability | Notice | The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Refuse to File: NDA and BLA Submissions to CDER."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. | 2017-12-13 | 2017 | 12 | https://www.federalregister.gov/documents/2017/12/13/2017-26791/refuse-to-file-new-drug-application-and-biologics-license-application-submissions-to-the-center-for | https://www.govinfo.gov/content/pkg/FR-2017-12-13/pdf/2017-26791.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Refuse to File: NDA and BLA Submissions to CDER."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... |