Expanded access allows patients to use investigational drugs outside of clinical trials. FDA Drug Info Rounds pharmacists discuss the requirements that must be met before FDA can authorize Expanded Access and discuss the safeguards in place to avoid exposing patients to unnecessary risks.
Drug Info Rounds are a series of training videos for practicing clinical and community pharmacists, and they are brought to you by pharmacists in the FDA’s Center for Drug Evaluation and Research (CDER), Office of Communications (OCOMM), Division of Drug Information (DDI). Our goal is to provide important and timely drug information to pharmacists so they can help patients make better medication decisions.
Posted on the FDA website on 30 October 2014