The upcoming reauthorization of PDUFA: What regulatory professionals need to know
The FDA and pharmaceutical industry are gearing up for the reauthorization of the Prescription Drug User Fee Act in 2022. The critical program helps to both fund and define the activities of the FDA, including the review of prescription drugs. For much of 2021, the FDA and pharmaceutical industry debated and negotiated what they would like to see in the next iteration of the PDUFA agreement, known as PDUFA VII. This webinar will discuss what both sides have committed to, the changes in store for the next agreement, what those changes could mean for the pharmaceutical and biopharmaceutical industries, and what’s next for the PDUFA agreement as it awaits signoff from Congress.
Speaker:
Alexander Gaffney, MS, RAC – Executive Director, AgencyIQ
Alexander Gaffney is the Executive Director of Life Sciences at POLITICO’s AgencyIQ, where he leads the team’s research and analysis of life sciences regulatory issues affecting the Food and Drug Administration. He also leads the team’s business development activities.
Alexander previously worked at PricewaterhouseCoopers where he led the firm’s analysis of life sciences regulatory issues as part of its Health Research Institute. Before joining PwC, he was Manager of Regulatory Intelligence at the Regulatory Affairs Professionals Society (RAPS), where he also was Managing Editor of the company’s flagship publication, Regulatory Focus. Alexander has a master’s degree in Regulatory Science from the University of Maryland and has held his Regulatory Affairs Certification (RAC) in US regulation since 2013. He also has a degree in Political Science from Providence College. He currently lives in the Washington, DC area with his wife and two dogs.
Regulatory Affairs Community Regulatory Intelligence WG is inviting you to a scheduled Zoom meeting.
When: Feb 8, 2022 12:00 PM Eastern Time (US and Canada)
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Meeting ID: 914 2138 9364
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https://diaglobal.zoom.us/j/91421389364?pwd=Zjk2ZlZtTU14Y2dkL3BzSDRPNHZMZz09