Reference:USA 21 CFR Part 314 09-Apr-2025 § 314.50
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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 | |
| Reference Details | |
|---|---|
| Module | Module 4 — Unit 4.2.5 |
| Scope | HM |
| Document part | § 314.50 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Case report form, Archiving, FDA, Regulatory submission |
Content
§ 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 report tabulations.[...] (2) Case report forms. [...] (3) Additional data. [...] (4) Presentation and format. [...]
