Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.31
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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 4 — Unit 4.4.0 |
| Scope | HM |
| Document part | § 312.31 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Amendment, Sponsor, Investigational drug (IMP), Requirements, FDA |
Content
§ 312.31 Information amendments. (a) Requirement for information amendment. A sponsor shall report in an information amendment essential information on the IND that is not within the scope of a protocol amendment, IND safety reports, or annual report. Examples of information requiring an information amendment include: (1) New toxicology, chemistry, or other technical information; or (2) A report regarding the discontinuance of a clinical investigation.
(b) Content and format of an information amendment [...] (c) When submitted. Information amendments to the IND should be submitted as necessary but, to the extent feasible, not more than every 30 days.
