Issue Date: July 31, 2020
Issued by: Center for Drug Evaluation and Research
Topic(s): Administrative / Procedural, Pediatric Product Development
Status: Final
Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Initial Pediatric Study Plans
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
Download the Guidance Document
