Bill Aims to Force Drug Makers to Register Trials of Products
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Democratic lawmakers in Congress introduced legislation yesterday that would require makers of drugs and medical devices to register clinical trials of their products in a public database when they start and report the test results on it.
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WASHINGTON -- Federal regulators charged with approving generic versions of the world's most expensive drugs should follow the lead of their cautious European counterparts, according to Senator Edward M. Kennedy . In Europe, requirements for approval are tailored to the complexity of an experimental drug and can include clinical trials that cost millions for generic manufacturers to conduct.
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The NHS is to come under pressure to weed out ineffective and obsolete treatments, by the drugs watchdog.
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Cancer patients are being put at risk because of the refusal of drug companies to publish the results of clinical trials, scientists claimed yesterday.
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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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The pharmaceutical lobby pushed back Wednesday against a renewed effort in Congress to pass a law enabling U.S. consumers to buy cheaper prescription drugs from Canada and other countries.
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Greater numbers of seriously ill patients could get experimental medicines under proposed federal guidelines released Monday that also would allow drug companies to charge for the medicines.
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Proposed legislation could spell changes across the pharmaceutical world.
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The FDA decides to debate the company's lead drug.
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The U.S. House of Representatives voted on Wednesday to give the Food and Drug Administration more power over drugmakers as part of an effort to better protect the public from dangerous medicines.
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A dozen editors of prestigious medical journals jointly announced yesterday they will refuse to publish drug research sponsored by pharmaceutical companies unless the studies are registered
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Legislation to be introduced within days in the US House and Senate would require drug companies to publicly register clinical trials and post the results on a government-run website, congressional staff members who are drafting the proposals said yesterday.
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Pharmaceutical companies and Alzheimer's patient advocates went to Britain's High Court on Monday in a bid to force the state-run health service to give all patients access to three drugs to treat the brain-destroying disease.
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A drug manufacturer has been found to infringe patents licensed by the maker of a rival drug.
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WASHINGTON - The Food and Drug Administration would gain authority to ensure the safety of prescription drugs, including the power to mandate label changes that warn of newly emerging risks, under a bill passed yesterday by the House.
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The pharmaceutical sues over patent infringement.
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OTTAWA (CP) - Admitting that drug patent regulations are unclear and subject to abuse, Ottawa is returning the rules governing competition between brand-name and generic drug makers.