Regulations.gov document
Guidance: Refuse to File-New Drug Application and Biologics License Application…
Notice · FDA-2017-D-6554 · posted Dec 13, 2017
Key facts
| Document ID | FDA-2017-D-6554-0001 |
|---|---|
| Title | Guidance: Refuse to File-New Drug Application and Biologics License Application Submissions to the Center for Drug Evaluation and Research |
| Document type | Notice |
| Subtype | Guidance |
| Agency | FDA |
| Docket | FDA-2017-D-6554 |
| Posted | Dec 13, 2017 |
| Federal Register citation | 82 FR 58615 |
| FR document number | 2017-26791 |
| Comment period opens | Dec 13, 2017 |
| Comments due | Feb 13, 2018 |
| Effective date | Dec 13, 2017 |
At a glance
- 1–9 Pages
- No Open for comment
- 1–9 Public comments on this docket
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