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Enrollment and Retention in 34 United States Pregnancy Registries Contrasted with the Manufacturer’s Capture of Spontaneous Reports for Exposed Pregnancies

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    Description

    Pregnancy registries and spontaneous reports are essential pharmacovigilance tools to evaluate drug safety during pregnancy. The aim of this study was to evaluate postmarket capture of exposed pregnancies.

    Author(s)

    Steven T. Bird PharmD, PhD, MS, Kate Gelperin MD, Lockwood Taylor PhD, MPH, Leyla Sahin MD, Hoda Hammad MS, MPH, Susan E. Andrade ScD, Mohamed A. Mohamoud PharmD, MPH, Sengwee Toh, ScD, Christian Hampp PhD

    Corresponding Author

    S.T. Bird, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD. Email steven.bird@fda.hhs.gov