Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.40 (b)
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| Document information | |
|---|---|
| Reference | USA 21 CFR Part 312 09-Apr-2025 |
| Validity area | USA |
| Scope(s) | HM |
| Document name | 21 CFR Part 312 |
| Version / Revision | 09-Apr-2025 |
| Status | Current |
| Document type | Legal act |
| Language(s) | EN |
| Description | Title 21 —Food and Drugs
Chapter I —Food and Drug Administration, Department of Health and Human Services Subchapter D—Drugs for Human Use Part 312 Investigational New Drug Application https://www.ecfr.gov/current/title-21 |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
| Reference Details | |
|---|---|
| Module | Module 1 — Unit 1.5.4 |
| Scope | HM |
| Document part | § 312.40
(b) |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Investigational drug (IMP), Requirements, Temporary halt, FDA, Clinical investigation |
Content
§ 312.40 General requirements for use of an investigational new drug in a clinical investigation. […] (b) An IND goes into effect: (1) Thirty days after FDA receives the IND, unless FDA notifies the sponsor that the investigations described in the IND are subject to a clinical hold under § 312.42; or (2) On earlier notification by FDA that the clinical investigations in the IND may begin. FDA will notify the sponsor in writing of the date it receives the IND. [...]
