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Vioxx Studies: Ghostwriters And Merck Sponsorship

While you thought that those Vioxx studies in medical journals were independent, hands-off affairs that may not have been necessarily true. An examination of medical journal articles about Vioxx and court documents from Vioxx lawsuits found that Merck employees or ghostwriters were frequently involved in various articles, but the primary authors were often academics who actually had little to do with the studies or didn’t always disclose financial ties to Merck.

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Improved drug regulation to ensure heart safety of non-heart drugs

Current regulatory policies should be strengthened to ensure acceptable cardiovascular safety of drugs developed primarily for non-cardiovascular medical problems, according to a recent presentation made by Dr. Jeffrey Borer, an authority in cardiovascular medicine and surgery at NewYork-Presbyterian Hospital/Weill Cornell Medical Center in New York City.

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Johnson & Johnson Tylenol recall includes infant medication

Johnson and Johnson have voluntarily recalled several Tylenol products for infants saying “rare instances of misuse” could lead to an overdose.

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Developing world could suffer if drug safety is not properly assessed

Millions of people could be put at risk because progress in getting the best medicines to the developing world is not being matched by an appropriate monitoring programme say the writers of an editorial in today’s BMJ.

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Safety of Chinese prescription drugs may be unwarranted

With Chinese manufacturers poised to increase exports of drug ingredients and perhaps even begin shipping finished drug products to the United States, an article http://pubs.acs.org/cen/business/85/8525bus1.html in Chemical & Engineering News (C&EN), ACS's weekly newsmagazine, questions allegations that foreign-made ingredients often are manufactured in factories that have never been inspected by the U. S. Food and Drug Administration (FDA).

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Drug surveillance system needs to be fixed

The current drug surveillance system needs to be fixed, argues an editorial in this week's BMJ.

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Calls For Stricter US Drug Safety Process

A growing number of critics are calling for stricter regulation of the pharmaceutical industry and how drugs are sold in the United States. The concern comes from medical experts, consumer groups and even from within the government agency in charge of the drug approval process.

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Deadly Prescription Drug Effects Six Years Before FDA

Northwestern University's Charles Bennett, M.D., is a super sleuth of potentially deadly prescription drug reactions. He leads a national SWAT team of doctors called RADAR (Research on Adverse Drug Events and Reports) based out of Northwestern's Feinberg School of Medicine. They swoop in to investigate early signs of trouble years before the Food and Drug Administration (FDA) takes notice.

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Prescription Drug Bill Requires FDA To Monitor Medication Safety

According to the prescription drug bill passed by the senat today, FDA will be required to monitor the pharmaceutical companies and the medications they make three years after the drugs are approved. This is a very significant move by the Senat to helping FDA to ensure the safety of prescription drugs.

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China to issue food and drug safety rules to prevent tragedies

With food poisoning and shoddy fake medicine cases frequently reported to have caused deaths in China, the government is expected to issue a comprehensive plan to track and trace food products.

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National Experts and NGOs call to Improve Drug Safety

Opposition to current drug safety legislation is growing, as a group of 22 experts on drug safety and regulation and a coalition of 12 patient, consumer, science, and public health organizations issue two separate open letters to lawmakers. The letter from FDA experts asks the lawmakers to not reauthorize the user fees system that finances the review of new drugs by the Food and Drug Administration (FDA).

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Taking wraps off drug safety data from clinical trials

For years, pharmaceutical companies have sought to restrict public access to drug safety data collected in clinical trials on the basis that it is proprietary information, arguing that competitors could use that information in the development of their own products. However, a number of recent cases of drugs found to have dangerous side effects after coming to market, such as the anti-inflammatory drug rofecoxib (Vioxx), have raised concerns about safety data being treated as confidential.

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