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Multiple & Drug Utilization in Pregnancy to Evaluate Enrollment in Pregnancy Registries Compared with Spontaneous Reports

Basic Details
Status
Complete
Last Updated
Thursday, July 26, 2018
Health Outcome(s)
drug utilization in pregnancy to evaluate enrollment in pregnancy registries compared with spontaneous reports
Purpose
Mini-Sentinel
Regulatory Determination / Use

FDA is using these findings, in addition to input received from the 2014 FDA Public Meeting, to evaluate safety data collection in pregnant women

Related Publication(s) and/or Presentation(s) (3)
Publication: 2016 ICPE Abstract Publication: Enrollment and Retention in 34 United States Pregnancy Registries Contrasted with the Manufacturer’s Capture of Spontaneous Reports for Exposed Pregnancies Publication: Utilization of Drugs with Pregnancy Exposure Registries During Pregnancy