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 responsibility for medical devices in […]
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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 helps to diagnose, treat or […]
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 all, of the 4,908 people […]
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oncology drug panel voted that Avastin is ineffective, unsafe and should have its approval for breast cancer treatment withdrawn, citing studies that have failed to show it is effective.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 drug will remain on […]
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 equally against two kinds of […]