PhRMA releases expanded access principles

The Pharmaceutical Research and Manufacturers of America on Wednesday updated its code of conduct for clinical trials to include a new chapter addressing expanded access to investigational therapies. The new text outlines parameters for granting access to investigational drugs and communicating about requests for access.

The newly-revised Principles on Conduct of Clinical Trials will take effect on June 1, 2015. PhRMA members agree to comply with the code as a condition for membership. ...