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October 24, 2011


FDA is getting ready to submit final recommendations for the fifth authorization of the Prescription Drug User Fee Act (PDUFA V) to Congress by January 2012. Details will be shaped by comments to the agency during a day-long public hearing on October 24. The new rules set up a process that emphasizes more communication early on between FDA and sponsors. The hope is that this move will increase the rate of drugs approved on the first try. PDUFA V also allows FDA to collect another $100 million from industry, to reach $3 billion a year. The agency expects to use the money to hire and train more staff to review applications. Read all the details here and tell us what you think about PDUFA V

Do you think FDA’s PDUFA V proposal will improve drug approval rates in the U.S.?

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