FDA ► Recently posted guidance documents

Recently posted guidance documents:

Guidance for Sponsors, Investigators, and Institutional Review Boards: Questions and Answers on Informed Consent Elements,21 CFR § 50.25(c) (Small Entity Compliance Guide)
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM291085.pdf

Guidance for IRBs,Clinical Investigators,and Sponsors: IRB Continuing Review After Clinical Investigation Approval
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM294558.pdf

Guidance for Industry and FDA Staff: FDA Acceptance of Foreign Clinical Studies Not Conducted Under an IND, Frequently Asked Questions
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM294729.pdf

Guidance for the Public, FDA Advisory Committee Members, and FDA Staff: Public Availability of Advisory Committee Members' Financial Interest Information and Waivers, Final Guidance
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM295372.pdf