Regulatory Explainer: FDA's Expanded Access (Compassionate Use) Program
By Alexander Gaffney, RAC -
Published 04 February 2014
In our latest Regulatory Explainer, we break down FDA's expanded access-sometimes referred to as compassionate use-regulations to understand how they work.
Categories: News, US, CDER, Biologics and biotechnology, Clinical, Drugs, Ethics
Tags: Investigational IND, Early Access Program, Compassionate Use Program, Regulatory Explainer, Compassionate Use, IND, Expanded Access