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# Content/Process Guide for Pediatric Study Plans
- URL: https://www.fdaweb.com/content-process-guide-for-pediatric-study-plans/
- Published: 2020-08-03T12:00:00.000Z
- Updated: 2026-09-14T16:23:29.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147340

FDA has posted a [final guidance](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/pediatric-study-plans-content-and-process-submitting-initial-pediatric-study-plans-and-amended?ref=fdaweb.com) entitled “Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Initial Pediatric Study Plans.” The guidance addresses applications for which a study plan is required and the timing and content of such plans. It also provides a template that is recommended to be used for study plan submissions.

A sponsor who is planning to submit a marketing application (or supplement to an application) for a new active ingredient, new indication, new dosage form, new dosing regimen, or new route of administration is required to submit a pediatric study plan unless the drug has an orphan designation, the guidance says. A biosimilar product that has not been determined to be interchangeable with the reference product is considered to have a new active ingredient for study plan purposes.