How drug-approval woes crept up on FDA
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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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If its latest drug isn't approved, the pharmaceutical could face trouble.
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Weighing the risks of Avandia, a diabetes drug, against its benefits is a difficult task.
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WASHINGTON &#151; Safety concerns about a GlaxoSmithKline diabetes drug prompted some Democratic lawmakers on Wednesday to rebuke the Food and Drug Administration and call for increased regulation of the pharmaceutical industry.
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The FDA is about to make it harder for drug-eluting stents to win its approval.
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The food and drug administration, the pharmaceuticals regulator in the United States, was yesterday fighting to head off a crisis in confidence among the American public.
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In the US drug industry, it often takes a disaster to bring change. Not until thousands of European babies were deformed by thalidomide in the late 1950s and early 1960s did Congress raise standards for approvals.
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WASHINGTON &#151; When federal regulators delayed approving a promising new prostate cancer therapy, patients and the drug&#146;s advocates reacted with more than disappointment.
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U.S. regulators have asked for more data  on Novartis AG's  diabetes drug Galvus, possibly  delaying approval of the potential blockbuster by a year, which  dented its shares while boosting its main rival's.
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The prescription drug industry has grown enormously in the past few years, to the tune of an estimated $200 billion every year. Consumers and medical professionals have sharpened their criticism of the industry
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New reports accuse another drug company of being too slow to pull a dangerous medication from the market and question the ability of the US federal Food and Drug Administration to protect Americans from such risks.
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A battle between insurers and drug companies could determine how many medicines will be available to beneficiaries.
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The story of COX-2 drugs is an example of how difficult it is for the F.D.A. to monitor the safety of drugs after they have been approved for the market.
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The Bush administration and some of its critics squared off yesterday over whether the Food and Drug Administration (FDA) is doing an adequate job overseeing drug safety, and whether the agency needs major reforms.
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FDA commissioner Andrew von Eschenbach took a tongue-lashing from members of Congress over the way his agency handled Avandia, the diabetes drug from GlaxoSmithKline that has come under scrutiny for alleged heart attack risks.
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Health care advocates, providers and FDA officials over the weekend &#39;sparred&#39; over alleged problems with the FDA prescription drug safety review process and the safety of five medications currently on the market, after an FDA safety reviewer on Thursday
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A day after troubling reports about the popular pain relief drug Celebrex, more questions are being asked about the approval process for such drugs.