In the FDA-regulated world, success is often defined as approval of a new product or indication based on two, well-controlled clinical trials. However, the scrutiny
It’s a refrain that is becoming familiar in the medical device industry: over-regulation is strangling innovation. Recently, however, this particular topic isn’t being championed by
Patient access to the emergency hormonal contraceptive “Plan B One-Step” has been one of the most combustible issues ever faced by FDA. It received more
The value of animal research in the life sciences is considered an NIH issue. FDA Matters believes that FDA and its stakeholders should be equally
For discussion purposes, let’s assume that there is a broad consensus that patients would benefit if new drugs and devices could get to the US
In most discussions of science and medicine, there is an implicit assumption that the human body is a machine—complex and biological, but still a machine.