It is truly amazing and very shocking, from 1996 to 1999, the U.S. food and Drug Administration (FDA) approved 157 new drugs. Compared to the period of 2006 to 2009 the FDA approved 74 drugs. However, NOT one of these approved drugs provided a cure for any serious illness! Diseases that destroy lives, diseases like [...]
Hormone therapy (ADT), using luteinizing hormone releasing hormone (LHRH) agonists or gonadatropin releasing hormone or GnRH agonists (Lupron, Zoladex, Trelstar, Viadur, Vantas, Eligard and Synarel ) have been known to have many side effects, some severe and potentially life threatening. Many of us believe that ADT is associated with cardiovascular disease and diabetes along with [...]
Provenge has finally received the long awaited approval from the FDA!!! We all celebrate and look forward to benefiting from its potential to extend our life. Provenge is the first immunologic therapy ever approved in the United States to treat cancer. (In Russia, Antigenics has received approval for an immunological treatment for kidney cancer). The [...]
According to a Reuters report, a spokeswomen from the FDA said yesterday that, “There is not going to be an additional advisory committee meeting” about the current application for the approval of Provenge. The FDA has the right to convene another meeting to discuss the results of the IMPACT trial, but it now looks as [...]
Finally, on Monday, Dendreon announced that it completed its Food and Drug Administration (FDA) application for the approval of Provenge (sipuleucel-T). Provenge is designed as a vaccine that stimulates the body's own immune system to fight prostate cancer. It is a different type of vaccine from what most of us knows as it is given [...]
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 [...]
