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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An experimental eye disease drug has been a boon to Eyetech Pharmaceuticals. But as the drug nears approval, many doctors are questioning its effectiveness.
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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 federal Food and Drug Administration to protect the public from such risks.
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The case of China's former FDA leader highlights the issues facing the country's pharmaceutical industry.
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The federal Food and Drug Administration, the agency charged with protecting an American public that is more and more dependent on pharmaceuticals, has been falling down on its job.
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U.S. lawmakers criticized the Food and Drug Administration's monitoring of the risks of a Sanofi-Aventis antibiotic and some other prescription drugs on Tuesday.
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The U.S. Food and Drug Administration is facing new questions about its ability to police the safety of medicines after they reach the market following concerns about a widely used diabetes 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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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 day after troubling reports about the popular pain relief drug Celebrex, more questions are being asked about the approval process for such drugs.
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Nearly 20 percent of U.S. Food and Drug Administration scientists surveyed in late 2002 said they were pressured to approve or recommend approval of a medicine despite their reservations about the drug's risks or effectiveness, according to documents made public on Thursday.
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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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New reports suggest another drug company moved too slowly to pull a dangerous medication from the market and question the Food and Drug Administration&#39;s ability to protect the public.
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The Food and Drug Administration over the past decade has shifted its budget away from monitoring the safety of drugs on the market, focusing more and more on approving new medicines.
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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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Startling testimony by an FDA drug safety reviewer about five popular medications has the medical world buzzing about how tightly the agency should be regulating new medications.
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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.