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FDA's Drug Promotion Advisory Reviews Taking Longer

 
• By Sue Sutter

FDA is having trouble meeting its internal goal of 45-day reviews for core launch materials due to complex issues that have required medical review division consultations, Office of Prescription Drug Promotion Director Abrams says.

Biopharma companies can improve their chances of getting timely FDA feedback on core product launch promotional materials through high-quality submissions and close interactions with review staff, the head of the agency's drug promotion review office said.

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