Scientists hit FDA on drug data
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Heart problems that pushed the painkillers Bextra and Vioxx off the market could have come to light earlier had federal regulators given outside researchers speedier access to raw safety data, according to a commentary written by Boston researchers.
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An unsurprising response from the FDA.
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The global pharmaceutical industry unveiled plans on Thursday to publish more data about trials of medicines in a bid to reassure patients following recent alarms over drug safety.
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The FDA decides to debate the company's lead drug.
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Almost one-fifth of the Food and Drug Administration scientists surveyed two years ago as part of an official review said they had been pressured to recommend approval of a new drug despite
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Drug makers are exploring the possibility of tying pharmaceutical prices to performance.
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WASHINGTON -- The Food and Drug Administration is preventing an agency scientist from presenting the largest, most up-to-date study of popular painkillers like Bextra, Celebrex and Vioxx during an FDA meeting next week on heart risks posed by the drugs, a US senator charged.
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Description: A scientist singles out five drugs as unsafe while testifying before a Senate committee on the Food and Drug Administration&#39;s oversight of Vioxx.
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The Food and Drug Administration has given a whistle-blower scientist permission to publish data indicating that as many as 139,000 people had heart attacks that may be linked to Vioxx, the scientist's lawyer said Monday.
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The global pharmaceutical industry  unveiled plans on Thursday to publish more data about trials of  medicines in a bid to reassure patients following recent alarms  over drug safety.
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Web data that showed a risk for a diabetes drug is likely to spur more efforts to publicly disclose drug study results.
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An interview with development-stage drugmaker Pharmacopeia.
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The U.S. Federal Trade Commission asked generic drug manufacturers for prices, cost data and sales information to help study the short- and long-term effects of authorized generics on prescription drug competition, the agency said on Friday.
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The world's four main pharmaceutical trade groups said Thursday that they will publish far more data about clinical drug trials than is now required by law.
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Dr David Graham, associate director for science in the Office of Drug Safety at FDA, alleged in a &quot;series of testy e-mail exchanges&quot; that agency officials &quot;delayed and demeaned&quot; the results of a study he conducted that found Vioxx -- a COX-2 inhibitor
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The world's biggest drug makers will  unveil plans on Thursday to publish more data about clinical  trials of their medicines in a bid to reassure patients about  their safety, according to industry sources.
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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.