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GEN Poll

Nov 07, 2011

Drug Approval Process

FDA’s proposed fifth authorization of the Prescription Drug User Fee Act (PDUFA V) largely drew support from drug developers and patient groups during the agency’s meeting held October 24 and in written comments sent in through October 31. All are eager to see Congress approve it early next year, even as they differ over how to evaluate the benefits and risks of new drugs. You can read about comments sent to the FDA here. The agency plans to finalize PDUFA V and forward it to Congress by January 15, 2012. While consumer and patient groups were unhappy about being left out of the process of drafting PDUFA V, they applauded the proposal for committing to incorporate patient perspectives in reviewing new drugs. Do you think such a move is warranted? 

Should the FDA take into account input from patients and consumers during its review of drug marketing applications?


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