Adaptive Design Clinical Trials for Drugs and Biologics

Guidance for Industry
Adaptive Design Clinical Trials for Drugs and Biologics
DRAFT GUIDANCE

This guidance document is being distributed for comment purposes only.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be submitted within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.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 301796-1700, 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)
February 2010
Clinical/Medical

pdf, 50 pages, 424kb:
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM201790.pdf