As new treatments, drugs and medical devices come to market the FDA is charged with making sure that they are both safe and perform as represented. Products that come under review include items such as human and animal drugs, blood and other biological products, medical devices, and foods. The process of evaluating these products has [...]
On the Prostate Problems Mailing List there has been some recent discussion and a large amount of confusion expressed about the need for and importance of surrogate end points for drug and treatment approval. I attempted to make a very simple clarification and recommendation about surrogates. Here it is, but slightly modified ……. Maybe I [...]
In the United Kingdom cancer patients who are terminal have the opportunity to take experimental drugs long before they would be allowed to in the United States. The UK Department of Health has authorized a network of 19 hospitals where patients who have no other hope of a cure can agree to take drugs which [...]