This article discusses examples of personalized medicine in industry as well as examples of FDA regulatory activities with respect to personalized medicine. "Personalized medicine" or what also has been referred to as "precision medicine"has a variety of definitions, ranging from broad to narrow. The European Union and the President's Council of Advisors on Science and Technology provide broad definitions for personalized medicine, while the National Academy of Science...

This article discusses the various US regulatory pathways for access to investigational drugs and medical devices outside a clinical trial. Patients requiring diagnosis, monitoring or treatment for a serious disease or condition rely on medical products (drugs including biologics and medical devices) approved by the US Food and Drug Administration (FDA). When appropriate therapeutic products are not available on the market, patients can enroll in clinical trials to acc...

Following is a free preview of a Regulatory Focus feature article, normally exclusively available to RAPS members. For information about becoming a member, visit Join RAPS . This article presents an overview of Canada's medical marijuana regulations regarding individual prescription access and compliance measures for licensed producers. The narcotic marijuana (spelled "marihuana" in most official Canadian government communications) is not an approved drug or medicin...