FDA Reveals Plan for Wider Access to Experimental Drugs
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The Food and Drug Administration yesterday unveiled a proposal designed to give thousands of seriously ill patients easier access to experimental treatments.
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Greater numbers of seriously ill patients could get experimental medicines under proposed federal guidelines released yesterday that would allow drug companies to charge for the medicines.
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Britain is to overhaul and open up its drug safety monitoring system, already viewed as one of the better schemes worldwide, in the wake of recent scandals over the side effects of some medicines. Patients will in future be able to view anonymous data on suspected adverse drug reactions on the Medicines and Healthcare Products Regulatory Agency's (MHRA) Web site, Health Minister Lord Warner said Monday.
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Jean Pierre Garnier, head of GlaxoSmithkline, says the FDA should have stronger powers - forcing pharmaceutical companies to carry out further tests on already approved drugs.
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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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Researchers should do more to tailor drugs specifically for children, the government is set to say on Tuesday.
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The Food and Drug Administrationâs proposed rules would allow drug and device makers to provide doctors with medical journal articles about product uses that have not been approved by the F.D.A.
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Faced with weak development pipelines that are putting a drag on stock prices, drug manufacturers are retooling the decades-old system of clinical trials to make it faster and cheaper.
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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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A previously unpublished internal survey of Food and Drug Administration scientists points to potentially dangerous gaps in the approval and marketing of prescription drugs, according to documents jointly released today by the Union of Concerned
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The government has given the go ahead for Internet-only pharmacies as part of a wider strategy to allow patients easier access to prescriptions and other pharmaceutical services.
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The U.S. Food and Drug Administration issued a new report on Tuesday describing potential risks of several medicines after criticism that it was lax in policing drugs once they were on the market.
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The FDA asks for more data about Avastin, which could be used to treat various cancers.
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A U.S. House of Representatives committee voted on Thursday to give the Food and Drug Administration more power to monitor the side effects of medicines after they reach the market.
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The approval of a new drug is a long-term opportunity.
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Proposed legislation could spell changes across the pharmaceutical world.
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Drug companies could soon make more experimental drugs available for a fee to more patients with serious or life-threatening diseases that have no approved treatments, under revised rules the U.S. Food and Drug Administration proposed on Monday.