By: Susan Heavey, Reuters WASHINGTON, 27 August 2010 – The U.S. Food and Drug Administration is cracking down on use of certain clinical trials that show a new drug is no worse than another already on the market, according to a government report released on Friday. Such trials, known as non-inferiority trials, are used when […]
SaneVax urges FDA and NCI to establish a reliable HPV genotyping test for virology-based cervical cancer prevention in patient care
By: Norma Erickson 06 November 2010 Last Tuesday, the SaneVax team sent a letter to Dr. Margaret Hamburg, FDA Commissioner, and Dr. Harold E. Varmus, Director of the National Cancer Institute (NCI), requesting the establishment of a reliable human papillomavirus (HPV) genotyping test to support the national virology-based cervical cancer prevention program for patient care. […]
FDA and CDC to Consider Gardasil for Anal Cancer Prevention
By: Sue Sutter 16 November 2010 A clinical reviewer for the Food and Drug Administration Center for Biologics Evaluation and Research sees no problem with using an anal dysplasia end point, or extrapolating male data to females, to support approval of Merck’s human papillomavirus vaccine Gardasil for prevention of anal cancer. Nevertheless, the agency is […]
GSK Vaccine Like Rotarix May Cause Fatal Bowel Problem
By: Dr. Mercola 16 October 2010 The Food and Drug Administration said preliminary results from a study in Mexico involving GlaxoSmithKline’s Rotarix vaccine suggest an increased risk of a serious bowel problem that could be fatal. A statement posted to the FDA’s website said the study showed an increased risk of intussusception in the 31-day […]
FDA: Gardasil approved to prevent anal cancer
FDA Press Release 22 December 2010 The U.S. Food and Drug Administration today approved the vaccine Gardasil for the prevention of anal cancer and associated precancerous lesions due to human papillomavirus (HPV) types 6, 11, 16, and 18 in people ages 9 through 26 years. Gardasil is already approved for the same age […]
