U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. Patient Counseling Information Section of Labeling for Human Prescription Drug and Biological Products — Content and Format
  1. Search for FDA Guidance Documents

GUIDANCE DOCUMENT

Patient Counseling Information Section of Labeling for Human Prescription Drug and Biological Products — Content and Format December 2014

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2013-D-1067
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

This guidance is intended to assist applicants in developing the PATIENT COUNSELING INFORMATION section of labeling required under § 201.57(c)(18) (21 CFR 201.57(c)(18)). 2 The recommendations in this guidance are intended to help ensure that this section of labeling is clear, useful, informative, and to the extent possible, consistent in content and format.
 

Submit Comments

Submit Comments Online

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:

Dockets Management
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-2013-D-1067.

Back to Top