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Press Release
Pew Commends Pharmaceutical User Fee Agreements, Urges Swift Action by FDA and Medical Device Industry
WASHINGTON – Allan Coukell, director of medical programs at the Pew Health Group, issued the following statement today, commenting on a package of agreements reauthorizing the U.S. Food and Drug Administration (FDA) user fee programs that fund agency oversight activities, known as the Prescription Drug User Fee Act (PDUFA), Generic Drug User Fee Act (GDUFA), and Biosimilars User Fee Act (BsUFA):
"We commend the FDA and the pharmaceutical industry for working together on agreements that support the agency’s review activities. Under PDUFA, the FDA has reduced the time it takes to approve new drugs. Now thanks to the first ever agreement with the generic drug makers, industry has made an investment in greater oversight of U.S. medicines made overseas.
"Unfortunately, the Medical Device User Fee Act (MDUFA) is not final. We urge the FDA and the medical device industry not to miss this opportunity to reach an agreement so that the agency will have the resources and tools it needs to protect consumers and ensure that innovative products come to market in a timely fashion."
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Pew Health Group
The Pew Health Group is the health and consumer-product safety arm of The Pew Charitable Trusts, a nonprofit organization that applies a rigorous, analytical approach to improve public policy, inform the public and stimulate civic life. www.pewtrusts.org/health.
The Pew Charitable Trusts and the Premier healthcare alliance sent the White House Office of Management and Budget a letter regarding the review of a Food and Drug Administration rule to establish a unique device identifier (UDI) system. Given the importance of this new device identification system to improve patient care and the missed statutory deadline, in this correspondence Josh Rising of Pew and Blair Childs of Premier strongly urged the Director of the Office of Management and Budget (OMB) to promptly complete review of the UDI final rule.
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A letter from Josh Rising — director of Pew's Medical Device Initiative — to The White House Office of Management and Budget, requesting a speedy review of regulations to develop a unique device identifier (UDI) system.
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