FDA
Click on the following link for the U.S. Food and Drug Administration (FDA) webpage.
U.S. Food and Drug Administration (FDA) Regulations and Guidance
Guidance documents do not create or confer any rights for or on any person and do not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statue, regulations, or both.
- 21 CFR 11: Electronic Records; Electronic Signatures
- 21 CFR 50: Protection of Human Subjects, Informed Consent
- 21 CFR 54: Financial Disclosure
- 21 CFR 56: Institutional Review Boards
- 21 CFR 312: Investigational New Drugs
- 21 CFR 314: FDA Approval to Market a New Drug (NDA)
- 21 CFR 600: Biologics, general
- 21 CFR 601: Biologics, licensing
- 21 CFR 812: Investigational Devices
- 21 CFR 814: Medical Devices, Pre-Market-Approval (PMA)
- 21 CFR 860: Medical Devices, Classification Procedures
- A guide to informed consent
- Device advice
- FAQ: IRB review of Medical Devices
- FDA Enforcement Activities
- FDA Regulations: special protections for children
- FDA Warning Letters
- Index, Information for FDA-regulated Industry Index
- Information for Health Professionals
- Off-Label and Investigational Use of Marketed Drugs, Biologics, and Medical Devices
- Significant Differences between HHS and FDA regulations
FDA has issued the guidance, “Questions and Answers on Informed Consent Elements, 21 CFR § 50.25(c)." This guidance is intended to help sponsors, investigators and Institutional Review Boards better understand the new informed consent requirement set forth in 21 CFR 50.25(c). The guidance will assist those involved in applicable FDA-regulated clinical trials better understand the new informed consent requirement, including small businesses
The document is now available using the following web link:
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM291085.pdf