> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Draft Guide on Pediatric Study Plans
- URL: https://www.fdaweb.com/fda-draft-guide-on-pediatric-study-plans/
- Published: 2016-03-08T12:00:00.000Z
- Updated: 2026-09-15T02:41:44.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135001

> FDA has released a [draft guidance](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM360507.pdf?ref=fdaweb.com) on “Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Initial Pediatric Study Plans” that addresses the agency’s current thinking on implementing requirements for such plans to be submitted under the Food Drug and Cosmetic Act’s section 505B(e). The document discusses who must submit a pediatric plan, when to submit, what to include in submissions, and a template that can be used.