FDA Repeats Itself With Cephalon's Fentora
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Doctors get a second warning about misusing the pain drug.
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Two years after the withdrawal of the painkiller Vioxx, a dysfunctional Food and Drug Administration still can't adequately track the safety of new drugs and respond quickly to problems, a panel of experts said Friday.
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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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The FDA's approval of Fentora comes just in time for the drug company.
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The White House says the Food and Drug administration is doing a &quot;spectacular&quot; job. Really? The FDA didn&#39;t respond to warning signs that block-buster painkillers like Celebrex and Vioxx increased the risk of heart attacks.
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Pfizer is the latest drug maker to warn that a product already on the market may pose serious health risks. It took outrage from activists in September to get the Food and Drug Administration to require warning
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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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FDA advisory panel isn't convinced that MEVACOR deserves OTC status.
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The same industrial chemical that led to a massive pet food recall was used by a U.S. manufacturer of ingredients for feeding livestock, fish and shrimp, health officials said Wednesday.
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The US Food and Drug Administration yesterday sought to distance itself from remarks by one of its top safety officials that raised concerns about key drugs made by Astrazeneca and Glaxo Smithkline.
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Cephalon Inc. warned doctors about deaths that have been linked to its Fentora pain drug for cancer patients, U.S. health regulators said on Thursday.
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The US Food and Drug Administration, under sharp criticism for its drug safety behavior involving anti-inflammatory drugs, antidepressants, and the silencing of its own drug safety scientists, has been offered a new name today: the Fraud and Drug
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GlaxoSmithKline PLC revealed Thursday that the U.S. Food and Drug Administration has declined to grant a priority review to its experimental cancer vaccine Cervarix, adding to pressure on the drug maker after controversy surrounding its diabetes drug Avandia.
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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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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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U.S. lawmakers criticized the Food  and Drug Administration's monitoring of the risks of the  antibiotic Ketek (Sanofi-Aventis) and some other prescription  drugs on Tuesday.
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Cephalon's promotion of its pain drug Actiq might have crossed the line.