Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products — Content and Format January 2023
Not for implementation. Contains non-binding recommendations.
- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Drug Evaluation and ResearchCenter 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The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled “Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products--Content and Format.”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for Human Prescription Drug and Biological Products--Content and Format” issued on March 29, 2010, and issuing this draft guidance.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2007-D-0201 .