Document:USA 21 CFR Part 314 09-Apr-2025
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| Document information | |
|---|---|
| Reference | USA 21 CFR Part 314 09-Apr-2025 |
| Validity area | USA |
| Scope(s) | HM |
| Document name | 21 CFR Part 314 |
| 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 314 Applications for FDA Approval to Market a New Drug https://www.ecfr.gov/current/title-21 |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
References
| Scope | Document part | Language | Preview | |
|---|---|---|---|---|
| USA 21 CFR Part 314 09-Apr-2025 § 314.126 | HM | § 314.126 | EN | § 314.126 Adequate and well-controlled studies. (a) The purpose of conducting clinical investigations of a drug is to distinguish the effect of a dru… |
| USA 21 CFR Part 314 09-Apr-2025 § 314.126 (4) - (5) | HM | § 314.126 (4) - (5) | EN | § 314.126 Adequate and well-controlled studies.
[...] (4) The method of assigning patients to treatment and control groups minimizes bias and is inten… |
| USA 21 CFR Part 314 09-Apr-2025 § 314.50 | HM | § 314.50 | EN | § 314.50 Content and format of an NDA.
(f) Case report forms and tabulations. The archival copy of the NDA is required to contain the following case r… |
