Posts Tagged ‘FDA’

FDA Advised to Scrap Approval Process for Medical Devices

Tweet In a report initially commissioned by the Food and Drug Administration, a 12 member panel of medical experts from the Institute of Medicine has recommended the U.S. government retire the 35-year-old system currently used to approve medical devices because it provides little or no assurance of safety for patients. The FDA was originally given […]

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FDA Proposes Regulating Mobile Health “Apps”

Tweet It is estimated that there are currently more than 17,000 medical applications available for a Smart-phone, tablet computer or personal digital assistant. These apps can range from calorie counters to programs that let doctors view medical scans on their phones. The FDA is proposing to regulate some of those applications, specifically any app that […]

Stop-smoking pill Chantix linked to heart problems

Tweet  A new  international study, led by researchers at Johns Hopkins University has  found the drug Chantix increased the risk of hospitalizations for heart problems by  72 percent. The study, analyzed 14 Pfizer-sponsored drug trials with 8,216 patients and found about one new heart attack or similar disorder for every 400 patients taking Chantix. In […]

FDA Advisers Vote Against Avastin for Advanced Breast Cancer Treatment

Tweet In three unanimous votes, the six members of the FDA oncology drug panel voted that Avastin is ineffective, unsafe and should have its approval for breast cancer treatment withdrawn, citing studies that have failed to show it is effective. The recommendation Wednesday came after two days of testimony from patients, doctors, and advocacy groups. […]

The FDA announces new Guidelines for Sunscreen Labels

Tweet The new regulations, which come into effect next year, will ban sunscreen manufacturers from claiming their products are waterproof or sweatproof because such claims are false,  officials have said. Instead, manufacturers can claim, in minutes, the amount of time the product is water-resistant, depending upon test results. The FDA says that sunscreens must protect […]

The Rise and Fall of Provigil – Part I

Tweet On July 22, 2010, the European Medicines Agency recommended restricting the use of modafinil. Doctors and patients should be advised to use the drug only for the treatment of narcolepsy and all other indications should be withdrawn from market authorization, the press release said. In addition to the brand-name, Provigil, marketed by Cephalon in […]