Regulations.gov document
Standardized Format for Electronic Submission of NDA and BLA Content for the Planning of…
Other · FDA-2018-D-0481 · posted Feb 21, 2018
Key facts
| Document ID | FDA-2018-D-0481-0002 |
|---|---|
| Title | Standardized Format for Electronic Submission of NDA and BLA Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for CDER Submissions; Guidance for Industry; Draft Guidance |
| Document type | Other |
| Subtype | Guidance |
| Agency | FDA |
| Docket | FDA-2018-D-0481 |
| Posted | Feb 21, 2018 |
| Comment period opens | Feb 21, 2018 |
| Comments due | Apr 18, 2018 |
At a glance
- No Open for comment
- 1–9 Public comments on this docket
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