Questions and Answers on Informed Consent Elements, 21 CFR § 50.25(c)
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).
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.