The purpose of this guidance is to provide information to sponsors regarding the submission of an initial pediatric study plan (iPSP) and any amendments to the iPSP. Specifically, this guidance addresses the Food and Drug Administration’s (FDA’s) current thinking regarding implementation of the requirement for sponsors to submit an iPSP as described in section 505B(e) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA).

This guidance addresses the following:

  • Who must submit an iPSP
  • When an iPSP must be submitted
  • What should be included in an iPSP
  • What should be included in a requested amendment to an agreed iPSP
  • A template that should be used for an iPSP submission

This guidance does not contain a discussion of general requirements for development of drugs for pediatric use under the Pediatric Research Equity Act (PREA) or the Best Pharmaceuticals for Children Act (BPCA).

This guidance revises the draft guidance for industry Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Pediatric Study Plans issued in July 2013. This revision includes additional clarifications regarding sections previously included in the 2013 guidance as well as new sections that have been added, including: section V.A., Materially Incomplete iPSPs, section VI., Relationship of Agreed iPSP to the Requirement to Submit a Pediatric Plan With an Application, section VII., Contents and Timing of Requested Amendment to an Initial PSP, section VIII., Non-Agreed Initial Pediatric Study Plans, and section IX., Reaching Agreement on the Non-Agreed Initial Pediatric Study Plan. Additionally, Appendix 1, Initial Pediatric Study Plan Template, has been updated.

Posted on the FDA website on 8 March 2016