Prescription Drug User Fee Act (PDUFA)
Prescription Drug User Fee Act (PDUFA) The Prescription Drug User Fee Act (PDUFA) was created by Congress in 1992 and authorizes FDA to collect fees from companies that produce certain human drug and biological products. Since the passage of PDUFA, user fees have played an important role in expediting the drug approval process.
On July 9, 2012, the President signed into law the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012. This new law includes the reauthorization of the Prescription Drug User Fee Act (PDUFA) that provides FDA with the necessary resources to maintain a predictable and efficient review process for human drug and biologic products. This is the fifth authorization of PDUFA that includes Title I of FDASIA and the performance goals and procedures for PDUFA V.
The new law ensures that FDA will continue to receive a source of stable and consistent funding during fiscal years 2013-2018 that will allow the agency to fulfill its mission to protect and promote public health by helping to bring to market critical new medicines for patients.
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This 3-hr virtual seminar on the FDA New Drug Approval Process will cover the NDA and ANDA review and approval process including a discussion of preparing NDAs and ANDAs, relevant meetings, timing, costs, approval requirements and other FDA regulatory requirements. The various existing regulatory approval pathways (the “full” NDA, the 505(b)(2) NDA and the ANDA) will be discussed.
This training provides an up-to-date understanding of regulatory requirements for the development and implementation of biomarkers in drug development programs, as well as highlights of the most recent FDA sources on general, imaging (Including PET) and pharmacogenomic biomarkers.
Drug safety training - factors to be considered - drug development - risk management - intellectual property - pharmacovigilance
