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Home » EMA Clarifies Reexamination Process for Pediatric Trial Plans
EMA Clarifies Reexamination Process for Pediatric Trial Plans
Drugmakers should notify the European Medicines Agency within 10 days of receiving an initial opinion on a pediatric investigation plan if they plan to request another review. The official request, due 20 days later, should include the procedure number and a detailed justification for requesting the reexamination, according to updated guidance issued Jan. 22.
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