Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products—Conte.pdf

Guidance for Industry Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products— Content and Format DRAFT GUIDANCE This guidance document is being distributed for comment purposes only.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be submitted within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.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 (CDER) Paul Hepp at 301-796-1538 or Lei Zhang at 301-796-1635; or (CBER) the Office of Communication, Outreach and Development at 301-827-1800 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) February 2009 Labeling Guidance for Industry Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products— Content and Format Additional copies are available from: Office of Communications, Division of Drug Information Center for Drug Evaluation and Research Food and Drug Administration 10903 New Hampshire Avenue