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Guidance Informed Consent Final Rule

Abstract:

FDA has prepared this guidance in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act. It is intended to help small businesses better understand the new informed consent requirements set forth in 21 CFR § 50.25(c)...

Type:
Statute
Date First Enacted:
Authors and Contributors:
FDA
Site link:
Read the Statute: Guidance Informed Consent Final Rule
URL Citation:
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/questions-and-answers-informed-consent-elements-21-cfr-ss-5025c
LawSeqSM Record Last Modified:
04/13/2026