Calls are mounting for revamp of FDA
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Just as the Enron scandal triggered an overhaul of corporate accounting practices, the nation&#39;s prescription drug crisis may prompt a sweeping revamp of
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Washington, Dec 16 : One-fifth of the US Food and Drug Administration (FDA) scientists surveyed as part of an official review have said they had been pressured to recommend approval of a new drug despite their reservations about its safety, effectiveness
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It would seem a drug executive&#39;s dream come true. A week ago Thursday, the secretary of health and human services summoned the top officials of MedImmune to his office in Washington to ask
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The FDA decides to debate the company's lead drug.
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Three drugs -- Vioxx, Ketek and Avandia -- are casting long shadows over the congressional debate on how to update and revise the 15-year-old system that has dramatically  sped up the process of bringing  prescription medicines to American consumers.
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Three drugs -- Vioxx, Ketek and Avandia -- are casting long shadows over the congressional debate on how to update and revise the 15-year-old system that has dramatically sped up the process of bringing prescription medicines to American consumers.
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Mylan Pharmaceuticals vowed yesterday to refile what it says will be a stronger federal complaint against the Food and Drug Administration over a ruling that has forced the company to compete with so-called &quot;authorized generics.&quot;
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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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Dec. 19--Pfizer, the world&#39;s biggest drug maker, and the rest of the pharmaceutical sector will come under renewed pressure this week after the Food and Drug Administration (FDA) warned doctors to consider
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Concerns over the approval of drugs that turned out to be dangerous have led Republicans and Democrats in the House and the Senate to call for investigations.
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The regulatory approval was also a boost for the embattled drugs sector. It was feared that, following a series of safety crises, the US Food and Drug Administration would get tougher on new drugs.
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The U.S. Food and Drug Administration said on Tuesday it would make organizational changes to improve internal communication about potential risks that emerge after a new drug reaches the market.
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The US Food and Drug Administration, facing a barrage of criticism from both within and outside the agency, announced plans Friday to improve the safety of drugs after they have been approved.
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European medical regulators have called on the worldâs leading pharmaceutical companies to improve their communications with authorities and surveillance of drugs, following frustration about Merckâs handling of the withdrawal of its anti-inflammatory
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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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Washington --- The Food and Drug Administration, accused in recent weeks of being cozy with the pharmaceutical industry, must open its practices to greater public scrutiny, says a top official of the agency&#39;s besieged Office of New Drugs.
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FDA efforts to move David Graham have stepped up since he criticized the agency's handling of Merck & Co. Inc.'s now-withdrawn Vioxx painkiller, said his lawyer.