Forum Session

Not Your Father's Drug Approval Process: FDAAA and the Evolving Pharmaceutical Marketplace
March 12, 2010


Michele J. Orza, ScD


The Food and Drug Administration Amendments Act of 2007 (FDAAA) adds significantly to the already substantial authorities of the U.S. Food and Drug Administration (FDA). With respect to drugs, FDAAA reauthorizes and expands existing programs, such as user fees, and adds new ones like those intended to enhance drug safety. This session examined the implementation of FDAAA and its impact on agency operations, the drug industry, and the public health.


Cole Werble and Michael McCaughan, Senior Editors, The RPM Report, and Founding Members, Prevision Policy; David Dorsey, Acting Deputy Commissioner for Policy, Planning and Budget, U.S. Food and Drug Administration; Peter K. Honig, MD, Managing Director, PH Regulatory and Medical Advisors, LLC; Andrea Masciale, Senior Director, Global Regulatory Affairs Strategic Policy and Support, Johnson & Johnson Pharmaceuticals Group

Slides from the presentations by Mr. Werble and Mr. McCaughan, Dr. Honig, and Ms. Masciale are available for download. Speakers' biographies are also available.

Related Materials

See FDA's Web site for more information about FDAAA.

In addition, congressional staff can access the Congressional Research Service’s report, "FDA Amendments Act of 2007 (P.L. 110-85)," by Erin D. Williamsand Susan Thaul, Order Code RL34465, published April 28, 2008.

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