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 âFood and Drugs
Chapter I âFood and Drug Administration, Department of Health and Human Services Subchapter DâDrugs 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⌠|
References
| Reference | Scope | Document part | Language | Preview |
|---|---|---|---|---|
| Reference: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 drug from other influences, such as spontaneous ... |
| Reference: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 intended to assure comparability of the groups with ... | ||
| Reference: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 report tabulations and case report forms: (1) Case ... |
