Guidance for Industry
Adaptive Design Clinical Trials
for Drugs and Biologics
This guidance document is being distributed for comment purposes only.
Comments and suggestions regarding this draft document should be submitted within 90 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publication in the Federal Register of the notice announcing the availability of the draft
guidance.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 Robert O’Neill or Sue-Jane Wang at 301
796-1700, Marc Walton at 301-796-2600 (CDER), or the Office of Communication, Outreach
and Development (CBER) at 800-835-4709 or 301-827-1800.
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research (CBER)