Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.21
From GxPlex
| 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 1.2.5 |
| Scope | HM |
| Document part | § 312.21 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Trial phase, Clinical investigation, Investigational drug (IMP) |
Content
§ 312.21 Phases of an investigation. An IND may be submitted for one or more phases of an investigation. The clinical investigation of a previously untested drug is generally divided into three phases. Although in general the phases are conducted sequentially, they may overlap. These three phases of an investigation are a follows:
(a) Phase 1. [...] (b) Phase 2 [...] (c) Phase 3 [...]
