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GUIDANCE DOCUMENT

Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Pediatric Study Plans March 2016

Draft

Not for implementation. Contains non-binding recommendations.

Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

The purpose of this guidance is to provide information to sponsors regarding the submission of 21 an initial pediatric study plan (iPSP) and any amendments to the iPSP. Specifically, this 22 guidance addresses the Food and Drug Administration’s (FDA’s) current thinking regarding 23 implementation of the requirement for sponsors to submit an iPSP as described in section 24 505B(e) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Food and 25 Drug Administration Safety and Innovation Act (FDASIA).2


Submit Comments

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:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.