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July 11, 2012

Wednesday FoREMS: PDUFA V: Important Changes for Risk Management Professionals

The Prescription Drug User Fee Act (PDUFA) reauthorization bill has been sent to the President for signature. The bill will reportedly include a series of agreed goals between industry and FDA, including the issuance of new benefit-risk management guidances, upcoming FDA workshops, and changes to the timing and content of meetings and submissions to FDA.

By being aware of these changes now, risk management professionals can begin to plan ahead for when PDUFA V is signed and promulgated by FDA.

  • Overview of PDUFA
  • Review of reported PDUFA V goals agreed between industry and FDA
  • Identification of PDUFA V goals that may impact risk management professionals
  • Panel Discussion
  • Gary Slatko, MD - Chief Medical Officer, ParagonRx
  • Marc DeLuca - Clinical Services Manager, ParagonRx
  • Kim Bullano, PharmD - Clinical Services Director, ParagonRx
  • Regina L. Ruben, Ph.D. - Pharmacovigilance and Risk Management Director, ParagonRx


Webinar Slide Set:




Session Replay:

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