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Human Subjects Division (HSD)

Regulatory Updates

FDA: Good Clinical Practice/Human Subject Protection Update

May 24, 2011 at 7:58am

FDA has issued new draft guidance, "Financial Disclosure by Clinical Investigators, Guidance for Clinical Investigators, Industry and FDA Staff."  The document is now available from FDA's web site at the following link:

http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM256525.pdf

This guidance is intended to assist clinical investigators, industry and FDA staff in interpreting and complying with the regulations governing financial disclosure by clinical investigators, 21 CFR part 54.

Comments to the draft guidance are due by July 25, 2011.