We Need to Report Serious Adverse Events or Serious Drug Side Effects to the FDA – How You Can Make a Report

The Food and Drug Administration (FDA) is charged with protecting the general health and well being of Americans with medicines and certain treatment equipment. Sometimes these medications or treatment equipment fail, don't work as indicated or cause serious, life threatening side effects. Reporting these events is important so the FDA can track and monitor these [...]

FDA and Medicare Regulation—Their Role And What Will Happen In the Future – Part One of a Two Part Post

Historically, I have been critical of the FDA, especially around the delay of the approval of Provenge. Now, it is time to take a look at the FDA and what I believe the future will be for this agency. I do first need to make it clear that I do believe that the FDA plays [...]

FDA Perspective on Developing Novel Combination Therapies – What We Need

Increasingly it has become obvious to me and to many other individuals that our current drug approval and development process has a basic flaw. If you go to research conferences you quickly learn that there is probably no magic bullet to stop any type of cancer, including advanced prostate cancer. Current drug development focuses on [...]