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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

Basic Details
Date
Tuesday, August 29, 2017
Type
Publication
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.

Materials

Drug Safety; August 2017. DOI: 10.1007/s40264-017-0591-5

Related Assessment(s)
2016 ICPE Poster: A Systematic Review of Enrollment and Retention in US Pregnancy Exposure Registries and Corresponding Pharmacovigilance Systems
Mini-Sentinel Drug Assessment: Multiple & Drug Utilization in Pregnancy to Evaluate Enrollment in Pregnancy Registries Compared with Spontaneous Reports
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