Issue Date: February 1, 1987
Issued by: Center for Drug Evaluation and Research
Topic(s): Clinical – Pharmacology
Status: Final
Format and Content of the Human Pharmacokinetics and Bioavailability Section of an Application
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).
Download the Guidance Document
