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FDA Clinical Trials

Supreme Court To Consider Federal Pre-Emption In Wyeth V. Levine

H. Sandra Chevalier-Batik · November 4, 2008 ·

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, … [Read more...] about Supreme Court To Consider Federal Pre-Emption In Wyeth V. Levine

Filed Under: Big Pharma Watch Tagged With: Bert Rein, Big Pharma Watch, Bush administration, Congress, dangerous product, Diana Levine, FDA, FDA Black Box Warning, FDA Clinical Trials, FDA Failure To Protect, federal law, Follow The Money, Henry J. Kaiser Family Foundation, Inc., Johnson & Johnson, Kaiser Daily, Kaiser Family Foundation, Legal Issues, Medical Malpractice / Litigation, Medtronic, nausea, New England Journal, Ortho Evra, Phenergan, Stephen Breyer, The Wall Street Journal, U.S. Supreme Court, United States, USD, Vermont, Vermont Supreme Court, Vioxx, Wall Street Journal, Wyeth, Your Body/Your Self, Zyprexa

Drug Web site raises important questions

H. Sandra Chevalier-Batik · October 24, 2008 ·

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 … [Read more...] about Drug Web site raises important questions

Filed Under: FDA Failure To Protect Tagged With: AERS, FDA Approvals, FDA Clinical Trials, FDA Failure To Protect, Food and Drug Administration, heart attack, Oates Institute for Experimental Therapeutics, Vanderbilt University School of Medicine

Researchers Question Wide Use of HPV Vaccines

H. Sandra Chevalier-Batik · August 21, 2008 ·

FINALLY! In June of 2006, my writing partner, Leslie Botha, and I, started writing articles cautioning women against the use of Gardasil® for girls and young women. We cited the limited nature of the clinical trials (the number, and ages of women tested) and the length of time … [Read more...] about Researchers Question Wide Use of HPV Vaccines

Filed Under: Big Pharma Watch, Cancer Research, Cervical Cancer, FDA Clinical Trials, FDA Failure To Protect, Follow The Money, HPV Infection, HPV Vaccine, Take Action! Tagged With: Big Pharma Watch, Cancer Research, Cervical Cancer, Children's Health, Exploitive Behavior, FDA Clinical Trials, FDA Failure To Protect, Follow The Money, Gynecology, Health Advisory, Health Care, Health Care Costs, HPV Infection, HPV Vaccine, My Opinion, Pediatrics, Reproductive Health, Take Action!

Your Guide to Reporting Problems to FDA

H. Sandra Chevalier-Batik · June 12, 2008 ·

Reporting any adverse events (unexpected side effects) to FDA after using a medical product, or other problems with any products that the agency regulates. Printer-friendly PDF (366 KB) On this page: Tips for Reporting Quick-Reference Chart for Reporting Problems … [Read more...] about Your Guide to Reporting Problems to FDA

Filed Under: Big Pharma Watch, FDA Clinical Trials Tagged With: Big Pharma Watch, FDA Clinical Trials, FDA Press Release, Health Advisory

FDA 101:

H. Sandra Chevalier-Batik · June 10, 2008 ·

How to Use the Consumer Complaint System and MedWatch On this page: Consumer Complaint Reporting Reporting Problems Can Spur Action MedWatch Reporting How to Report to MedWatch Problems to Report to MedWatch Reporting Emergencies FDA Consumer Complaint … [Read more...] about FDA 101:

Filed Under: FDA Clinical Trials, Take Action! Tagged With: FDA Approvals, FDA Clinical Trials, FDA Press Release, Health Advisory, Take Action!

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