Regulations.gov document
Investigational New Drug Applications--Determining Whether Human Research Studies Can Be…
Notice · FDA-2010-D-0503 · posted Oct 30, 2015
Key facts
| Document ID | FDA-2010-D-0503-0075 |
|---|---|
| Title | Investigational New Drug Applications--Determining Whether Human Research Studies Can Be Conducted Without an Investigational New Drug Application; Guidance for Clinical Investigators, Sponsors, and Institutional Review Boards; Partial Stay and Republication of Guidance |
| Document type | Notice |
| Subtype | Notice of Stay of Action |
| Agency | FDA |
| Docket | FDA-2010-D-0503 |
| Posted | Oct 30, 2015 |
| Federal Register citation | 80 FR 66907 |
| FR document number | 2015-27729 |
| Comment period opens | Oct 30, 2015 |
| Effective date | Oct 30, 2015 |
At a glance
- 1–9 Pages
- 10–99 Public comments on this docket
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