FDA User Fees 2012: How Innovation Helps Patients and Jobs

Wednesday, April 18, 2012 - 10:15am
2123 Rayburn
Background Documents and Information: 

This legislative hearing focused on reauthorization of the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee Act (MDUFA), which expired at the end of September 2012. PDUFA reauthorization will support the approval and expediting of prescription drugs to the marketplace, while the reauthorization of MDUFA and improvements to medical device regulation will help bring greater predictability, consistency, and transparency to the approval of these important medical products. Both PDUFA and MDUFA play important roles in ensuring patients receive quality care and access to new therapies while promoting innovation and job creation.

Hearing Notice

Background Memo

Discussion Draft

Panel I
Janet Woodcock, M.D.
Center for Drug Evaluation and Research
U.S. Food and Drug Administration
Jeffrey E. Shuren, M.D., J.D.
Center for Devices and Radiological Health
U.S. Food and Drug Administration
Panel II
David E. Wheadon, M.D.
Senior Vice President, Scientific and Regulatory Affairs
Pharmaceutical Research and Manufacturers of America
Sara Radcliffe
Executive Vice President, Health
Biotechnology Industry Organization
David Gaugh, R.Ph.
Vice President, Regulatory Sciences
Generic Pharmaceutical Association
Joseph A. Levitt, J.D.
Hogan Lovells US LLP
on behalf of Advanced Medical Technology Association
Allan Coukell
Director of Medical Programs, Pew Health Group
The Pew Charitable Trusts