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Document:USA 21 CFR Part 314 09-Apr-2025: Difference between revisions

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|DocDescription=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
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|reference=USA  21 CFR Part 314  09-Apr-2025
|reference=USA  21 CFR Part 314  09-Apr-2025
|validity_area=USA
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Line 37: Line 18:
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== References ==
{| class="wikitable"
! 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 ...
|}
</noinclude>

Latest revision as of 14:15, 16 July 2026


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

 ScopeDocument partLanguagePreview
USA 21 CFR Part 314 09-Apr-2025 § 314.126HM§ 314.126EN§ 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 § 314.50HM§ 314.50EN§ 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…
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