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# Guide on Pediatric Study Plans
- URL: https://www.fdaweb.com/guide-on-pediatric-study-plans/
- Published: 2020-08-03T12:00:00.000Z
- Updated: 2026-09-14T16:23:34.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5147333

*Federal Register* notice: FDA has made available a final guidance entitled “Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Initial Pediatric Study Plans.” The document addresses FDA’s current thinking on implementing the requirement for sponsors to submit a pediatric study plan. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2020-08-03/pdf/2020-16785.pdf?ref=fdaweb.com).