Guidance for IRBs, Clinical Investigators, and Sponsors

This draft guidance, when finalized, will represent the Food and Drug Administration's (FDA's or Agency's) current thinking on this topic.  It does not create or confer any rights for or on any person and does not operate to bind FDA or the public.  You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.  If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance.  If you cannot identify the appropriate FDA staff, call the appropriate number listed under "For Questions Regarding This Document" below.

Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.  Submit comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD  20852.  All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.

For questions regarding this draft document contact (OGCP) Marsha Melvin at 

, (CDER) Kristen Miller at 301-796-0762, (CBER) Office of Communication, Outreach and Development at 800-835-4709 or 240-402-7800, or (CDRH) Sheila Brown at 301-796-6563 (CDRH).

Office of Good Clinical Practice
  Office of Special Medical Programs, Office of Medical Products and Tobacco
  Food and Drug Administration
  10903 New Hampshire Avenue
  WO32-5103
  Silver Spring, MD 20993
  (Tel) (301) 796-8340

U.S. Department of Health and Human Services
  Food and Drug Administration
  Office of Good Clinical Practice
  Center for Drug Evaluation and Research
  Center for Biologics Evaluation and Research
  Center for Devices and Radiological Health

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This guidance document is being distributed for comment purposes only.