Guidance for Clinical Investigators, Industry, and FDA Staff

Food and Drug Administration: February 25, 2013

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. This document is a revision of the Guidance for Industry: Financial Disclosure by Clinical Investigators dated March 20, 2001. In order to address issues raised by the Office of the Inspector General (OIG), Department of Health and Human Services, in its report, OEI-05- 07-00730, The Food and Drug Administration’s Oversight of Clinical Investigators’ Financial Information2 as well as questions FDA has received from industry and the public, FDA issued a revised guidance in draft in May 2011 for public comment. Comments were received from 13 individuals and entities, which were considered in preparing this final guidance. FDA encourages applicants and sponsors to contact the agency for advice concerning specific circumstances regarding financial disclosures that may raise concerns as early in the product development process as possible.

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in agency guidances means that something is suggested or recommended, but not required. Read more