Assessing the FDA&#39;s Approval Process
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Description: NPR&#39;s Scott Simon talks with a former commissioner of the Food and Drug Administration, Dr. David Kessler, about the FDA&#39;s complications with the arthritis drug Vioxx and other drugs, and the process by which drugs are approved.
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Dozens of former and current Food and Drug Administration officials, outside scientists and advocates for patients say that the agency&#39;s efforts to monitor the ill effects of drugs that
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Merck&#39;s (MRK :NYSE - news - research) decision to withdraw its popular arthritis drug Vioxx from the market in late September has raised questions about the process leading up to its regulatory approval in 1999 as well as the importance of subsequent
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WASHINGTON/NEW YORK  - A U.S. Food and Drug  Administration reviewer who has accused the agency of being lax  in monitoring drug safety on Thursday said five medicines on  the market need closer scrutiny.
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The US Food and Drug Administration today announced a five-step program to bolster drug safety evaluations. The news comes after controversy over the recall of the arthritis drug Vioxx and risks to children on antidepressants.
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The Bush administration and some of its critics squared off over whether the Food and Drug Administration is doing an adequate job overseeing drug safety, and whether the agency needs major reforms. White House Chief of Staff Andrew H. Card Jr. said it is doing a "spectacular" job.
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Here's what a newly approved drug looks like.
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The Food and Drug Administration of the US found itself in the midst of a rather unpleasant controversy. Recently the chief of Cleveland Clinic Foundationâs department of cardiovascular medicine blamed this
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Two revelations last week of Food and Drug Administration foot-dragging place in doubt whether the agency can effectively serve and protect consumers.
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FDA has launched a review of its records of the August 2001 withdrawal from the market of Bayer&#39;s statin Baycol in light of allegations made last week that the pharmaceutical company was aware of the risks associated with the drug but failed to inform FDA
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Dr. Steven Galson, acting director of the Food and Drug Administration&#39;s Center for Drug Evaluation, announced Friday that the FDA will review five popular drugs whose safety is being questioned.
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The US Food and Drug Administration, under fire for its alleged failure to monitor the safety of drugs after they have been approved, is now facing criticism over its lack of leadership during the Bush administration.
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Critics charge conflict of interest in a system where pharmaceutical giants fund the regulatory process. By Alexandra Marks | Staff writer of The Christian Science Monitor.
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WASHINGTON -- A Food and Drug Administration official is defending the agency&#39;s action with regards to Vioxx. The drug was taken off the market Sept.
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Provenge supporters weigh in on an FDA decision.
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WASHINGTON The Food and Drug Administration has ordered a sweeping review of studies involving prescription painkillers like Celebrex and Bextra.
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FDA advisory panel gives the nod to its heart drug.