Compassionate Use for Unapproved Drugs

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

Malecare Provides Comments to Dr. Torti, the new Acting Director of the FDA

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. Torti Appointed Acting Director of the FDA

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 [...]

Who Should Become the New FDA Commissioner?

The Food and Drug Administration (FDA) is one of the major governmental entities that has a significant, direct and immediate affect on any of us who has any illness. All men with prostate cancer have had their life and their deaths impacted by the FDA. This impact has not been on just a few of [...]

A Priority FDA Review for Toremifene 80 mg for Bone Protection

GTx announced in a company media release that it has requested that the FDA consider its new drug application (NDA) for the use of toremifene 80 mg to prevent bone fractures in men with prostate cancer receiving androgen deprivation therapy (ADT). GTx has asked for a priority review of its application stating that “there are [...]

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