|Project Title||Sequential Surveillance for Drug Safety in a Regulatory Environment|
Monday, March 5, 2018
The purpose of this paper is to help regulatory scientists develop and refine recommendations about which drug safety questions are most amenable to sequential surveillance. The authors consider newly marketed drugs that will be monitored for a limited set of prespecified safety outcomes. The paper's focus is on implementation of sequential surveillance in electronic health data, with consideration of the additional challenges posed by a distributed database environment.