The pediatric Written Request, in order to obtain Pediatric Exclusivity under BPCA, is about the Sponsor performing studies voluntarily where information in pediatrics is desirable. Pediatric Study Plans under PREA are required studies for the intended indication. Therefore, the timing of the two are not related as they are not the same kinds of studies. For example, if you are developing a product in adults, the PSP is meant to agree with FDA on the required study plan in pediatrics. If the product might also be useful in a pediatric population for a different indication, you can apply for the Written Request for that indication.
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Glen Park PharmD
Executive Director, Regulatory Affairs and Quality Assurance
Jersey City NJ
United States
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Original Message:
Sent: 16-Jul-2020 11:46
From: Anonymous Member
Subject: Pediatric Written Request
This message was posted by a user wishing to remain anonymous
Dear Experts,
Before a sponsor can request a pediatric written request, does the initial pediatric study plan need to be agreed upon with the review division?
Thank you for all of your help!