Pediatric Study Waiver, Deferral Determinations Could Harm Approvals, Firms Tell FDA
Comments on draft guidance say agency’s belated decisions on requests for waivers or deferrals of pediatric studies could lead to “refuse to file” determinations; FDA has missed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.
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The agency also should explain the potential consequences for sponsors if enrollment goals are not met, stakeholders say in comments on the DAP draft guidance. Some commenters urged the FDA to apply waiver criteria flexibly, especially for rare diseases.
