The FDA Drug Safety Bill: how safe are our drugs?

Abstract

The world of drug safety is undergoing major changes in the US, Europe and elsewhere following several major drug withdrawals, billion dollar lawsuits, NGO studies of drug safety and widespread media attention in the US. Some of the events of the past few years are reviewed along with some of the reactions and changes in the FDA and the field of drug safety followed by the author's conclusions and views on the future of drug safety.

Keywords::

• FDA
• FDA Revitalization Act
• FDA Amendments Act of 2007
• PDUFA
• user fees