Classification of Transvaginal Mesh Pop Repair An advisory panel for the U.S. Food & Drug Administration (FDA) voiced support for an agency proposal to reclassify transvaginal mesh devices used to repair pelvic organ prolapse (POP) as high risk, or Class III. If the FDA does go forward with the change, manufacturers of would … [Read more...]
Transvaginal Mesh for POP Repair Should be Classified
FDA Taking Hard Look at Avastin
Avastin as Breast Cancer Treatment. U.S. health regulators are questioning whether Avastin is really an effective treatment for breast cancer. A Food & Drug Administration (FDA) advisory panel is scheduled to discuss Avastin tomorrow. Avastin was the first approved therapy designed to inhibit angiogenesis, the process by which new … [Read more...]
Avandia Decision Looms for FDA
FDA Will Discuss The Safety Of Avandia. In two weeks, a U.S. Food & Drug Administration (FDA) advisory panel will meet to discuss the safety of the controversial diabetes drug, Avandia. In the past, the Avandia issue has sharply divided the agency. However, over the past several years, concerns about Avandia side effects have … [Read more...]
Advisory Panel on Menaflex Yields Few Answers
No firm conclusion regarding ReGen Biologic's controversial Menaflex knee device. No firm conclusion regarding ReGen Biologic's controversial Menaflex knee device came out of an advisory panel meeting convened by the Food & Drug Administration (FDA) yesterday. According to The Wall Street Journal, the panel’s chairman, John … [Read more...]
Gardasil for Boys Gets OK From FDA Advisory Panel
Gardasil for Boys Gets OK From FDA. Gardasil, the HPV vaccine currently marketed to young girls and women, may soon be available for boys According to a CNN report, a Food & Drug Administration (FDA) advisory panel has recommended that Gardasil be approved for boys and young men aged 9 to 26 for protection against genital warts … [Read more...]
Mevacor OTC Status
Mevacor Over-the-Counter Status. Mevacor, a statin medication that treats high cholesterol, could soon be sold as an over-the-counter drug if Merck & Co. has its way. The Food & Drug Administration (FDA) is considering the pharmaceutical company’s application to sell a low dose version of Mevacor without a … [Read more...]
