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Disease-Of-The-Quarter Club: FDA Plans 20 Patient Network Meetings Over Five Years

 
• By Martin Berman-Gorvine

PDUFA V framework to involve patients in the creation of the risk-benefit criteria for various diseases kicks off before the legislation is even enacted.

Patient networks will have a chance to provide input on 20 different disease areas through four meetings per year FDA plans to hold in the next five years, following the expected reauthorization of the Prescription Drug User Fee Act.

“In PDUFA V, we are taking that framework of benefit-risk and saying patients who have that disease, have a stake in the development and review process, and they are in a unique position to contribute and inform the development process, particularly … [on] severity of the condition and degree of unmet medical need,” Theresa

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• By Cathy Kelly

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• By Bridget Silverman

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