有哪些信誉好的足球投注网站Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products—Conte.pdf
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Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products—Conte
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DRAFT GUIDANCE
This guidance document is being distributed for comment purposes only.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publication in the Federal Register of the notice announcing the availability of the draft
guidance.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
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