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. Pediatric Information Incorporated Into Human Prescription Drug and Biological Products Labeling Good Review Practice
  1. Search for FDA Guidance Documents

GUIDANCE DOCUMENT

Pediatric Information Incorporated Into Human Prescription Drug and Biological Products Labeling Good Review Practice March 2019

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2013-D-0169
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research
Center for Drug Evaluation and Research

This guidance is intended to assist applicants in determining the appropriate placement and content of pediatric information in human prescription drug and biological product labeling as described in the regulations for the content and format of labeling for human prescription drug and biological products.

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-0169.

Back to Top