FDA plans to only issue pediatric exclusivity for new studies — not just those required under PREA
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 on which pediatric studies to conduct for new drugs.
Whereas the agency said there are times when it currently issues these written requests (WRs) and the subsequent pediatric-related exclusivity solely for studies required under the Pediatric Research Equity Act, or PREA, the agency said in a new draft guidance that it will now only offer exclusivity “for those sponsors who conduct additional pediatric studies — beyond what is required under PREA — that may produce health benefits in children.”
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