Guidance for Industry

Animal Models—Essential Elements to Address Efficacy Under the Animal Rule

DRAFT GUIDANCE

This guidance document is being distributed for comment purposes only.

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be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.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 Rosemary Roberts, CDER, at 301-796-2210 or the Office of Communications, Training, and Manufacturers Assistance (CBER), 301-8271800 or 800-835-4709.

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)

January 2009 Pharm/Tox



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