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The Bush administration is requesting funding of $1.49 billion for the FDA in fiscal 2005 and $350 million in drug industry user fees, according to FDA acting Commissioner Lester Crawford.
The FDA should take advantage of an ambiguity in federal law to require dietary supplement makers to file all known safety data before marketing a new compound, according to a new report from the Institute of Medicine and the National Research Council of the National Academies.
The number of complaints and disputes against the Center for Devices and Radiological Health (CDRH) more than doubled in 2003, according to agency ombudsman Les Weinstein’s annual report released March 31.
Integrating mortality data into trial endpoints and throughout the total product life cycle is key for clinical trial sponsors, says Bram Zuckerman, director of the cardiovascular devices division at the FDA’s Center for Devices and Radiological Health.
A Florida sterilization firm’s inadequate response to an FDA warning letter has provoked the agency to withhold export certificates and device approvals from the company until quality system (QS) improvements are made.
Larry Pilot, a partner at the Washington, D.C.-based law firm of McKenna, Long & Aldridge, has petitioned the FDA to remove a misleading statement from Form 483s that infers the quality system regulation (QSR) requires devicemakers to identify and correct violations.
Performance reports reveal that the FDA is still a long way from meeting targeted goals contained in the Medical Device User Fee and Modernization Act of 2002 (MDUFAMA), particularly with regards to accelerating the review process for breakthrough technologies and expedited review products.
Former FDA Commissioner Mark McClellan’s exit will have no immediate impact on the Center for Devices and Radiological Health’s (CDRH’s) current practice of targeting routinely violative devicemakers for tougher enforcement action, according to Tim Ulatowski, director of CDRH’s Office of Compliance.