Drug regulators too low on independence dosage
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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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Not every drug invented in the laboratory is worth developing into a marketable product.
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In the US drug industry, it often takes a disaster to bring change. Not until thousands of European babies were deformed by thalidomide in the late 1950s and early 1960s did Congress raise standards for approvals.
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Common children's cold and cough medicines are coming under scrutiny from federal drug regulators, who say the remedies and their recommended doses have not been studied enough in children, a newspaper reported.
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If its latest drug isn't approved, the pharmaceutical could face trouble.
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The Motley Fool - Pharmaceutical investors often forget that places beyond the United States and European Union have their own regulatory bodies that approve drugs -- and that some of these markets can be quite lucrative. Canada, Japan, and Australia are home to some of the biggest economies in the world, and they all have their own independent drug-regulation entities.
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More openness is needed over clinical drug trial results  to stop them being distorted, leading medical journals say.
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In Christopher Rowland's recent article, a Medicare official characterizes FDA drug labeling policy as setting ``minimum guidelines in terms of what people should be achieving" for red blood cell counts ( ``As kidney drug doses rise, so do warnings," Sept. 14 ).
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Dr David Graham told a Senate panel that five well known drugs, which are currently on the market, needed to be looked at more closely - this sent share values down for many drug companies.
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Federal advisers who met last week to consider whether to restrict doses of popular antianemia drugs were themselves under scrutiny during the hearing. The Food and Drug Administration is considering a top-to-bottom reshaping of how it picks and uses the outside scientists who serve on the agency's advisory panels.
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The Medicines Company reacquires its own drug.
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Consumer Reports' effort to rate drugs offers a lesson to pharmaceutical companies.
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Government regulators now look to approve as quickly as possible medicines whose benefits exceed their risks.
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When a great launch of a good drug is not enough.
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The Government has stopped short of endorsing two of the main recommendations of the Shipman Inquiry to restrict doctors&#39; access to controlled drugs.
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Regulators would get more authority over drugs sold without a prescription under a bill by three Democrats.
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The Food and Drug Administration needs more staff, funding and authority over the drug industry to better track the safety of medicines after they reach the market, an Institute of Medicine report said Friday.