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
FDA Clinical Trials
Drug Web site raises important questions
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
Researchers Question Wide Use of HPV Vaccines
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
Your Guide to Reporting Problems to FDA
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
FDA 101:
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: