The Alliance of Specialty Medicine wrote to the US Food and Drug Administration (FDA) in response to their revised “Guidance for Industry: Distributing Scientific and Medical Publications on Unapproved New Uses – Recommended Practices.”
In the letter, the Alliance outlines its concern that the guidance inappropriately restricts specialty physicians′ access to scientific information provided by manufacturers on the safe and effective use of medical products, including drugs, devices and biologics.
The referenced Alliance position statement on physician-directed applications, aka “off-label”, is also attached.
Click here to read letter to FDA
Click here to read Alliance position statement on “off label”
