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Ssmedley
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Please clarify: PDUFA timing begins when the company submits the new drug application to the FDA - so is it the postmark date or receipt date by FDA? Thx.
What is PDUFA?
I used to have a much beloved co-worker who was not in healthcare, but upon hearing the term "PDUFA" - standing for the Prescription Drug User Fee Act - for the first time during a meeting, shouted out "What the hell is PDUFA?" After that, PDUFA became his nickname. Almost no one called hi...
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Jul 26, 2010
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