The FDA recently issued a draft guidance on financial disclosure by clinical investigators, intended to assist researchers, industry, and FDA staff in interpreting and complying with regulations found in the Code of Federal Regulations Title 21, Part 54. The draft is being distributed for comment purposes only. The document is a revision of a guidance issued in March 2001, and can be found in its entirety here: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM256525.pdf.
Notice announcing the availability of the draft guidance was published in the Federal Register on May 24, 2011. Commenters have until July 25, 2011, to submit comments and suggestions, which should be directed to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm 1061, Rockville, MD 20852, or electronically, to http://www.regulations.gov. All comments should be identified with the docket number FDA-1999-D-0792.
For questions regarding the document, contact Marsha Melvin, Office of Good Clinical Practice, at 301-796-3340; Leah Ripper, Center for Drug Evaluation and Research, at 301-796- 1282; Sheila Brown, Center for Devices and Radiological Health, at 301-796-6563; and Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research, at 800-835-4709 or 301-827-1800. ■