> ## Content Index
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# Guidance on Pediatric Study Plans Content & Process
- URL: https://www.fdaweb.com/guidance-on-pediatric-study-plans-content-process/
- Published: 2016-03-09T12:00:00.000Z
- Updated: 2026-09-15T02:42:21.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5135026

*Federal Register* Notice: FDA is making available a draft guidance for industry entitled *Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Initial Pediatric Study Plans*. It revises the draft guidance entitled *Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Pediatric Study Plans* issued 7/15/13\. To download this guidance, click [here.](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM360507.pdf?ref=fdaweb.com) To view this notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-03-09/pdf/2016-05223.pdf?ref=fdaweb.com).