Seeking a Slim Victory, Drugmakers Press FDA
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Industry launches intense drives to develop new pills and persuade the agency to make it easier for weight-loss drugs to get on the market.
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After years of falling short, advocates of requiring the Food and Drug Administration to regulate tobacco are again waging that fight in Congress -- and this time, they say, the odds are in their favor. Really.
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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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New technology could lead to safer, more effective drugs.
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Pfizer plans to ask or approval of torcetrapib, a heart drug crucial to the companyÂs future, despite evidence that the drug increases blood pressure.
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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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U.S. health officials said on Friday  they would review whether to take regulatory action over Merck  & Co Inc and Schering-Plough's cholesterol medicine Vytorin  following the drug's failure to work better than a generic drug  in a study of plaque build-up in neck arteries.
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Drugmakers get part of the job done outside of the U.S.
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U.S. health officials said on Friday they would review whether to take regulatory action over Merck & Co Inc  and Schering-Plough's  cholesterol medicine Vytorin following the drug's failure to work better than a generic drug in a study of plaque build-up in neck arteries.
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A month after a new U.S. law  encouraging the development of medicines to counter  bioterrorism, some drugmakers are lobbying for more incentives  to make products that may never be used.
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In the face of growing public distrust, the US Food and Drug Administration remains unpersuasive in claiming that its review of prescription drugs is sufficient or places the consumer first.
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Proposed legislation could spell changes across the pharmaceutical world.
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Roche Holding AG and GlaxoSmithKline  said on Wednesday they asked U.S. regulators to approve an  intravenous form of their osteoporosis drug that could be  administered far less frequently.
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U.S. regulators need more clinical trials before they can approve heart-scan contrast agent MS-325 from Germany's Schering and U.S. partner Epix Pharmaceuticals, the companies said on Friday.
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The Food and Drug Administration on Monday issued guidelines it hopes will prompt drugmakers to use tiny radio tracking chips on their product packaging to help thwart counterfeiters.
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The Food and Drug Administration announcement comes as a response to criticism that the government has reacted too slowly to the dangers posed by popular supplements.
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A month after a new U.S. law encouraging the development of medicines to counter bioterrorism, some drugmakers are lobbying for more incentives to make products that may never be used.