Regulations.gov document
Guidance for Clinical Investigators, Sponsors, and Institutional Review Boards on…
Notice · FDA-2010-D-0503 · posted Feb 6, 2014
Key facts
| Document ID | FDA-2010-D-0503-0017 |
|---|---|
| Title | Guidance for Clinical Investigators, Sponsors, and Institutional Review Boards on Investigational New Drug Applications—Determining Whether Human Research Studies Can Be Conducted Without an Investigational New Drug Application; Reopening of the Comment Period |
| Document type | Notice |
| Subtype | Request for Comments |
| Agency | FDA |
| Docket | FDA-2010-D-0503 |
| Posted | Feb 6, 2014 |
| Federal Register citation | 79 FR 7204 |
| FR document number | 2014-02550 |
| Comment period opens | Feb 6, 2014 |
| Comments due | Apr 8, 2014 |
| Effective date | Feb 6, 2014 |
At a glance
- 1–9 Pages
- No Open for comment
- 10–99 Public comments on this docket
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