May 22, 2023 02:52 PM EDT

FDA plans to only issue pediatric exclusivity for new studies — not just those required under PREA

Zachary Brennan

Senior Editor

The FDA is scaling back when it will grant up to two 6-month periods of exclusivity to pharma sponsors once they complete FDA-mandated written requests …

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FDA plans to only issue pediatric exclusivity for new studies — not just those required under PREA

Zachary Brennan

Senior Editor

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FDA plans to on­ly is­sue pe­di­atric ex­clu­siv­i­ty for new stud­ies — not just those re­quired un­der PREA

Senior Editor

Sign up to read this article for free.

Celldex Therapeutics

Hampton, NJ, USA

FDA plans to only issue pediatric exclusivity for new studies — not just those required under PREA