Tag Archives: PDUFA

From the 3/12 Show – FDA User Fees and Protecting the Fox

In 1992, Congress created the Prescription Drug User Fee Act (PDUFA).  The intent was to collect additional revenue from the drug companies (Pharma) for the FDA to obtain additional staff to help expedite the approval process for pharmaceuticals.  It can … Continue reading

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From the 6/3 Show – For the Senate: Integrity Loses 96 to 1

An incredible story was missed last week by the national media. The Prescription Drug User Fee Act (PDUFA) was created by Congress in 1992 http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/default.htm In summary, the FDA collects fees from the drug companies to initiate the approval process … Continue reading

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