Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products — Content and Format January 2023

GUIDANCE DOCUMENT

• Docket Number: FDA-2007-D-0201
• Issued by: Center for Drug Evaluation and Research; Center for Biologics Evaluation and Research

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled “Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products--Content and Format.” This guidance is intended to assist applicants in developing the DOSAGE AND ADMINISTRATION section of labeling. The purpose of this guidance is to assist applicants in ensuring that the DOSAGE AND ADMINISTRATION section contains the dosage- and administration-related information needed for safe and effective use of a drug and that the information is clear, concise, and presented in a manner that is pertinent and understandable to health care practitioners. We are withdrawing the guidance for industry entitled “Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products--Content and Format” issued on March 29, 2010, and issuing this draft guidance.

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