Pediatric Study Planning With FDA, EMA To Be More Closely Aligned
Beginning in January, FDA will require initial pediatric study plans be submitted after the end-of-Phase II meeting, rather than well into Phase III, which is expected to improve planning and expand coordination with EMA.
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Based on designations, FDA already could have enough products in the pipeline to trigger the mandatory program stop and assessment.
Comments on draft guidance say agency’s belated decisions on requests for waivers or deferrals of pediatric studies could lead to “refuse to file” determinations; FDA has missed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.
Venture capitalist suggests the agency should keep both issues in mind when it orders a sponsor to conduct more trials or submit additional data in order to bring down the cost of drug development.