The U.S. Food and Drug Administration's Mini‐Sentinel program: status and direction
The U.S. Food and Drug Administration's Mini‐Sentinel program: status and direction
The Mini-Sentinel is a pilot program that is developing methods, tools, resources, policies, and procedures to facilitate the use of routinely collected electronic healthcare data to perform active surveillance of the safety of marketed medical products, including drugs, biologics, and medical devices. The U.S. Food and Drug Administration (FDA) initiated …