Regulations.gov document
Guidance for Clinical Investigators, Sponsors, and Institutional Review Boards on…
Notice · FDA-2010-D-0503 · posted Sep 10, 2013
Key facts
| Document ID | FDA-2010-D-0503-0015 |
|---|---|
| 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; Availability |
| Document type | Notice |
| Subtype | Notice of Availability |
| Agency | FDA |
| Docket | FDA-2010-D-0503 |
| Posted | Sep 10, 2013 |
| Federal Register citation | 78 FR 55262 |
| FR document number | 2013-21889 |
| Comment period opens | Sep 10, 2013 |
| Effective date | Sep 10, 2013 |
At a glance
- 1–9 Pages
- 10–99 Public comments on this docket
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