Content/Process Guide for Pediatric Study Plans

FDA has posted a final guidance 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.