FDA’s 2011 Draft Guidance on Financial Disclosure by Clinical Investigators – Overview of Recommendations

• By: Staff Editor
• Date: September 16, 2011

The FDA released draft guidance in May 2011 to assist clinical investigators, industry and FDA staff in interpreting and complying with regulations governing financial disclosures by clinical investigators, 21 CFR Part 54.

This article gives an overview of the recommendations included in the draft guidance. Comments on these draft guidelines were due by July 25, 2011.