Speed, Safety, and Industry Funding — From PDUFA I to PDUFA VI image

The New England Journal of Medicine, December 7, 2017
Jonathan J. Darrow (Student Fellow Alumnus), Jerry Avorn, and Aaron S. Kesselheim


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From the paper:

In August, President Donald Trump signed into law the sixth version of key legislation for the Food and Drug Administration (FDA), known as the Prescription Drug User Fee Act (PDUFA VI). The legislation continues a policy that authorizes the agency to collect user fees from pharmaceutical companies, providing funds that the FDA uses to hire additional staff to review new drug products and thereby reduce approval times. PDUFA VI is part of the FDA Reauthorization Act of 2017 (FDARA),1 which also renewed similar user-fee programs for medical devices, generic drugs, and biosimilars.


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