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Press Release
Pew Applauds Enactment of User Fee Legislation, Urges Its Swift Implementation
WASHINGTON—President Barack Obama today signed into law the Food and Drug Administration Safety and Innovation Act, which supports the U.S. Food and Drug Administration’s drug and device reviews and includes other measures to benefit patients.
"By signing the FDA Safety and Innovation Act, President Obama has ensured that the FDA will have the resources and authority it needs to promote the development of safe, effective and innovative medical products that Americans need," said Allan Coukell, director of medical programs at the Pew Health Group.
"This Administration should recognize the broad, bipartisan support this bill has earned and implement it without delay."
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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Nearly a year after the enactment of the Generating Antibiotic Incentives Now Act, the U.S. Food and Drug Administration has released draft guidance for industry on developing antibacterial therapies for patients with unmet medical needs.
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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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