Reauthorization of PDUFA: How Will You Be Affected?
Wednesday, August 22 2012
1:00 pm – 2:15 pm
Webinar - Reauthorization of the Prescription Drug User Fee Act (PDUFA): How Will You Be Affected?
Time: 1 p.m. to 2:15 p.m. Eastern
The prescription drug user fees provided by PDUFA are an integral part of the FDA's ability to efficiently review new drugs. PDUFA fees allow the FDA to hire additional staff, and give it the tools and resources to make the drug approval process thorough, objective, and transparent. The recently authorized PDUFA V will provide the FDA with the tools, resources and responsibilities it needs to bring new medicines to patients safely and efficiently, and more predictably, helping to ensure the United States remains the world's leader in biomedical innovation.
CHI-California Healthcare Institute, in collaboration with Merrill DataSite® and Aptiv Solutions, would like to invite you to this complimentary webinar that will address the provisions of the Agency-industry negotiated agreement, as well as additional and related provisions added during congressional consideration, and what it all means for the biopharmaceutical industry.
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