Docket Number:
FDA-2013-D-0814
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

The purpose of this guidance is to provide recommendations to sponsors regarding the submission of an initial pediatric study plan (iPSP) and any amendments to the iPSP. Specifically, this guidance provides the current thinking of the Food and Drug Administration (FDA) regarding implementation of the requirement for sponsors to submit an iPSP, described in section 505B(e) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
This guidance addresses the following:

 • Applications for which an iPSP is required
• Timing of an iPSP submission
• Content of an iPSP
• Content and timing of a requested amendment to an agreed iPSP
• A template that is recommend to be used for an iPSP submission

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-0814.