The FDA did introduce its Critical Path initiative in 2004. But, even these expedited processes have become bogged down. The FDA has responded to the political winds and become cautious after the negative publicity it received from the withdrawals of drugs like Rezulin and Vioxx. The best and most recent delay in the prostate cancer [...]
An article in today's New York Times about obtaining drugs under the compassionate use clause boiled my blood. I am not usually one without words, but this story has left me speechless, or wordless. I can not add anything to the story, it speaks for itself and makes me cry. Joel T Nowak MA, MSW
There is nothing more frustration that the current methods used by the FDA to approve drugs. The theory is great, but how it gets translated into our real world is killer, I mean a literal killer of men. The FDA wants assurances that before they approve a drug that it really works, or shows efficacy. [...]
Last Friday's post included information about the recent appointment of Dr. Frank M. Torti as the Acting Director of the FDA. Dr. Torti has invited public comments about the future direction of the FDA. As a representative of Malecare, I have provided specific feedback to Dr. Torti. The following post includes my comments to him. [...]
Dr. Frank M. Torti, M.D., MPH has just been appointed as the Acting Commissioner of Food and Drugs (FDA). He has been a prominent clinician, scientist and researcher in molecular oncology. Until his appointment at the FDA as Principal Deputy Commissioner and first Chief Scientist in April 2008, Dr. Torti had served the as Charles [...]