Its time to look at the faces of lives lost… In the early 1990s, faced with protests by AIDS activists about the glacier-like approval of potential life saving drugs, the Clinton administration changed the FDA drug approval process. They allowed pharmaceutical companies to “fast track life-saving” drugs by absorbing the extra costs involved. The unintended [...]
Goal Is to Provide Signs of Possibility Of Adverse Effect By JARED A. FAVOLE Wall Street Journal WASHINGTON The Food and Drug Administration on Friday unveiled a report listing 20 drugs that the agency is investigating for potential side effects, as part of a new policy to warn patients and health-care professionals as early [...]
As Reported on KVUE News, Sunday February 15, 2009… It was a hot issue here in Texas a couple of years ago. Now Gardasil, the vaccine against the virus that causes cervical caner, is back in the spotlight. Gabi Swank, a 16-year-old from Wichita, Kansas, says she and other girls are dying from the side-effects [...]
DeLauro Seeks Info From FDA Amid Political Influence Concerns By Jared A. Favole, Of DOW JONES NEWSWIRES WASHINGTON -(Dow Jones)- Congresswoman Rep. Rosa DeLauro, concerned about political influence in device and drug approvals, wants details about what products the Food and Drug Administration has approved in the last several months. She fears that industry influence [...]
Vaccine Watchdog Group Calls for Transparency WASHINGTON–(BUSINESS WIRE)–The National Vaccine Information Center (NVIC) is calling on the Centers for Disease Control (CDC) and Food and Drug Administration (FDA) to publicly release the study design, data and names of principal investigators involved in a statement this week maintaining that Gardasil vaccine is safe with no serious [...]
The U.S. Supreme Court next week will begin hearing the case of Wyeth v. Levine, which centers on the question of whether FDA approval of a drug warning label pre-empts product safety suits brought in state courts, the Wall Street Journal reports (Mundy/Wang, Wall Street Journal, 10/27). The case involves Diana Levine, who lost her [...]
By DAN RODEN, M.D. • October 10, 2008 Dr. Dan Roden is professor of medicine and pharmacology, director of the Oates Institute for Experimental Therapeutics, and assistant vice chancellor for personalized medicine at Vanderbilt University School of Medicine. The Food and Drug Administration recently announced a public Web site listing potential drug side effects it [...]
A Recent CNN Article lead with this headline… Gardasil® Deaths, Gardasil® Side Effects, Gardasil® Paralysis – Is the HPV Vaccine Given to Prevent Cervical Cancer Causing More Medical Problems? A vaccine designed to prevent cervical cancer is coming under fresh scrutiny amid thousands of complaints linking it to a range of health problems. Gardasil® has [...]
FDA Releases Draft Guidance on Regulation of Genetically Engineered Animals Printer-friendly PDF (420 KB) On this page: Genetic Engineering Benefits of GE Animals GE Animals Regulated Under New Animal Drug Provisions The Food and Drug Administration (FDA) is inviting the public to comment on draft guidance that discusses FDA’s approach to regulating genetically engineered (GE) [...]
FDA News FOR IMMEDIATE RELEASE September 12, 2008 Media Inquiries: Karen Riley, 301-827-6242 Consumer Inquiries: 888-INFO-FDA FDA Approves Expanded Uses for Gardasil® to Include Preventing Certain Vulvar and Vaginal Cancers The U.S. Food and Drug Administration today announced the approval of the vaccine Gardasil for the prevention of vaginal and vulvar cancer caused by Human [...]
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