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Pediatric Study Waiver, Deferral Determinations Could Harm Approvals, Firms Tell FDA

 
• By Sarah Karlin-Smith

Comments on draft guidance say agency’s belated decisions on requests for waivers or deferrals of pediatric studies could lead to “refuse to file” determinations; FDA has missed statutory deadline to promulgate regulations on pediatric study plans.

FDA needs to make formal determinations about whether a sponsor is granted a waiver or deferral of pediatric studies earlier in the drug development process, PhRMA, BIO and other industry stakeholders say, arguing that without swifter action, the agency is setting companies up for incomplete NDA and “refuse to file” determinations.

The comments come in response to a July 2013 draft guidance on the content and process for submitting...

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