Tag: regular approval

The FDA’s accelerated drug approval program is failing to protect cancer patients

Drug approval is a process that should be and, for the most part, is rooted in rigorous science. However, there is always a countervailing pressure to approve new drugs rapidly, particularly in cancer. That's why the FDA created the accelerated approval program in the early 1990s. Unfortunately, increasingly this approval process appears to be failing us in oncology. Reform is needed.