In a final rule published in the Federal Register on December 13, 1994, FDA revised the "Pediatric Use" subsection of the labeling for human prescription drugs to provide for the inclusion of more complete information about the use of a drug or biological product in the pediatric population [21 CFR 201.57 (f)(9)]. As a result, many application holders are proposing changes in their labeling under 21 CFR 314.70 or 601.12. This guidance document discusses the content and format of these pediatric use supplements. Under the rule, FDA may approve a drug for pediatric use based on adequate and well-controlled studies in adults, with other information supporting pediatric use. In such cases, the agency will have concluded that the course of the disease and effects of the drug are sufficiently similar in adults and the pediatric population to permit extrapolation from the adult efficacy data to pediatric patients. The agency encourages sponsors to cooperate and work together in supporting this conclusion for drugs that are in the same class and are used for the same disease or disorder.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.