Post Tagged with: "FDA"

Risperdal Gynecomastia Latest Lawsuit A Loss for J&J

Risperdal Gynecomastia Latest Lawsuit A Loss for J&J

Tweet The number of lawsuits filed against the long time corporate giant Johnson & Johnson continue to grow. Risperdal, an atypical anti-psychotic drug developed by Johnson & Johnson in an effort to combat the symptoms associated with the mental health disorders such as schizophrenia, bipolar disorder and in some cases autism in children is currently under scrutiny. The reported gynecomastia side […]

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FDA Advised to Scrap Approval Process for Medical Devices

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 responsibility for medical devices in […]

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FDA Proposes Regulating Mobile Health “Apps”

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 helps to diagnose, treat or […]

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Stop-smoking pill Chantix linked to heart problems

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 all, of the 4,908 people […]

FDA Advisers Vote Against Avastin for Advanced Breast Cancer Treatment

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 drug will remain on […]

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