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© Oxford University Press 2007.
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Institute of Medicine, Congress Seek Solutions to FDA's Safety Woes Through Reform, Funding
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An Institute of Medicine report has identified gaping holes in the ability of the U.S. Food and Drug Administration to ensure the safety of new drugs, but experts say the proposals don't solve possibly the biggest obstacle to safer drugs: inadequate funding.
The IOM's Committee on the Assessment of the U.S. Drug Safety System released their preliminary findings in September, after a series of public meetings held over 15 months. The report contains recommendations for reforming the center within FDA that is responsible primarily for both drug approval and postmarketing safety monitoring.
"Underlying our 25 recommendations is the fundamental view that the interests of the public are best served when safety and efficacy are considered together. However, factors including, but not limited to, the current organizational culture of the Center
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B. A. Chabner and T. G. Roberts The FDA in 2006: Reasons for Optimism Oncologist, March 1, 2007; 12(3): 247 - 249. [Full Text] [PDF] |
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