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Pediatric Cancer Studies: US FDA Eyes Waiver Framework For Same-In-Class Drugs

 
• By Sue Sutter

Advisory committee says planned waivers for molecularly targeted studies should take into account comparative adult efficacy and toxicity data for multiple drugs in the same class, as well as differences in product attributes, such as route of administration and dosing schedule; unmet clinical need should have less influence on decision to grant waivers, panelists said.

Framework
US FDA wants to build a transparent framework that it can consistently apply to decisionmaking about pediatric study waivers for cancer drugs. • Source: Shutterstock

The US Food and Drug Administration should take into account comparative efficacy and toxicity data in adults, as well as differences in dosage forms, routes of administration and dosing schedules, when evaluating planned waivers of pediatric studies for multiple same-in-class cancer drugs.

However, the degree of unmet clinical need in a specific pediatric cancer setting should have less influence on whether it...

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