FDA Regulations

FDA Regulations

U.S. Food and Drug Administration (FDA) Regulations and Guidance

Click on the following link for the U.S. Food and Drug Administration (FDA) webpage

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.

FDA Pages

Code of Federal Regulations (CFR) Title 21
FDA Guidance and Information Sheets
FDA Commonly Used Links
FDA Issues Guidance on New Informed Consent Requirements

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: