In his blog post on FDAVoice, Peter Lurie MD, MPH, associate FDA commissioner for public health strategy and analysis, announced the introduction of a draft form and a draft guideline that can be used by a physician to request access to an experimental drug or biological product that is still under development.
Today, I had the pleasure of announcing an important measure intended to help streamline expanded access to investigational drugs. We heard concerns from patients and physicians that the process for gaining access to investigational drugs was too difficult, and pulled together a team to find a way to make that process simpler.
Today, we’re introducing a much simpler draft form for comment that, when finalized, should accelerate patient access to investigational drugs. We know what an important tool this will be for physicians who treat those patients with serious or immediately life-threatening diseases or conditions for which there are no comparable alternative treatments.
Link to the blog post on the FDA website: http://1.usa.gov/1BUwo6R