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GUIDANCE DOCUMENT

Format and Content of the Human Pharmacokinetics and Bioavailability Section of an Application February 1987

Download the Final Guidance Document
Final
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

Biopharmaceutics studies are required by Part 320, Title 21, and by the Waxman-Hatch Amendments to the Federal Food, Drug and Cosmetic Act (the act).

Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.

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