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. […]
Conflicts of Interest in the Losing Cancer War
Posted by Norma Erickson, SaneVax 15 September 2010 This article was written by Samuel S. Epstein, MD, Chairman of the Cancer Prevention Coalition, and Quentin D. Young, MD, Chairman of the Health and Medicine Policy Research Group. Although it was originally published on 4 March 2004, the information contained within is still timely. It […]
HHS provides grants to assist WHO in fighting flu in developing countries
By: Jeffery Bigongiari 1 October 2010 The U.S. Department of Health and Human Services’ Biomedical Advanced Research Development Authority has awarded three sets of grants that total $10.4 million in an effort to assist the World Health Organization’s plan to strengthen the capacity of developing countries to produce influenza vaccine. Read the entire […]
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 […]
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