FDA Hearing. What FDA Failed to Disclose: 1991, 2006.
AHRP Testimony presented by Vera Sharav, December 2006. PowerPoint slides (843 kb file).
AHRP Testimony presented by Vera Sharav, December 2006. PowerPoint slides (843 kb file).
The FDA has just released its “Guidance on Drug Safety Information” abandoning its own proposed ‘DrugWatch Site Guideliens (2005), http://www.fda.gov/cder/guidance/6657dft.htm replacing it with an *asterisk and an impossible to find location on the Center for Drug Evaluation and Research (CDER) web page. A mere * is supposed to convey what…
It is difficult to comprehend, why the Obama administration, which has made cost-cutting a legislative centerpiece of healthcare reform, would remove the most potent, financial penalty in its existing legal arsenal from its settlement with Pfizer.
Research Protection: SCIENCE / Fed Paper Mon, 28 Oct 2002 SCIENCE magazine (below) reported about “the bumpy road” of Dr. Greg Koski’s tenure as director of the federal Office of Human Research Protections (OHRP), and how his resignation is being perceived by some. An article in The FEDERAL PAPER focused…
Anthrax Global Press Conference Friday, April 1, at 2:00 PM: Reunion of Heavy Metal Music Band To Raise Awareness Against Forced Drugs Wed, 30 Mar 2005 An unusual global press conference will kick off a week-end of heavy metal music and a public awareness campign. The press conference is scheduled…
Unless Congress acts to overrule the FDA, research disasters such as occurred in London, when six healthy men were exposed to an experimental substance that brought them close to death, are likely to occur with increased frequency.
Jeffrey Drazen editor NEJM Turns Activist on Drug Trials Thu, 26 May 2005 Journal editors, one by one are trying to retrieve the integrity of their publications, at last recognizing that the pharamaceutical industry is a corrupting factor in medical research and the information disseminated about medicine. Jeffrey Drazen who…