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

Project Title Enrollment and Retention in 34 United States Pregnancy Registries Contrasted with the Manufacturer’s Capture of Spontaneous Reports for Exposed Pregnancies
Date
Tuesday, August 29, 2017
Location

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

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.

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

Authors

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

Related Assessments
2016 ICPE Poster: A Systematic Review of Enrollment and Retention in US Pregnancy Exposure Registries and Corresponding Pharmacovigilance Systems
Publication Type
Publication
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