Sequential Surveillance for Drug Safety in a Regulatory Environment

    Basic Details
    Date
    Monday, March 5, 2018
    Type
    Publication
    Description

    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.

    Author(s)

    David Martin MD, MPH; Joshua J. Gagne PharmD, ScD; Susan Gruber PhD, MPH; Rima Izem PhD; Jennifer C. Nelson PhD; Michael D. Nguyen MD; Rita Ouellet-Hellstrom PhD, MPH; Sebastian Schneeweiss MD, ScD; Sengwee Toh ScD; Alexander M. Walker MD, PhD

    Corresponding Author
    D. Martin, Center for Drug Evaluation and Research, FDA, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA. Email: david.martin@fda.hhs.gov