accelerated approval – STREAM research

FDA: Lapdog or Listener?

Sociology of Health and Illness sociologist John Abraham (photo credit: eddiemcfish 2008)

The Need for Speed: GAO Reports on Accelerated Approval

Several blog posts ago, I wrote about the policy of accelerated approval (briefly, a mechanism whereby new drugs can be approved for sale by the FDA before definitive evidence of efficacy and safety are available). In that post, I reported on a recent paper where the authors claimed that, all things considered, accelerated approval enabled… Continue reading The Need for Speed: GAO Reports on Accelerated Approval

Accelerated Approval: Safe at Any Speed?

Drug regulatory authorities like the FDA have a mandate to protect public health by requiring and evaluating evidence of safety and efficacy before licensing new drugs for commercial sale. But for decades now, patient advocates have argued that FDA bureaucracy kills by keeping promising drugs from the IV’s of terminal patients. In response to these… Continue reading Accelerated Approval: Safe at Any Speed?