The number of patient registries is increasing in general and, more specifically, the number focused on biopharmaceutical product safety.

The focus on drug safety has never been so crucial, and sponsors must meet significant challenges in bringing safe and effective drugs to market. As safety monitoring expectations continue to increase, so do the use and complexity of specialized monitoring committees to provide additional safety oversight in clinical trials.

A REMS is an FDA-mandated program that incorporates one or more tools to help ensure the benefits of a specific drug outweigh its risks.