Trends in pregnancy labeling and data quality for US-approved pharmaceuticals.

  title={Trends in pregnancy labeling and data quality for US-approved pharmaceuticals.},
  author={Maryann E Mazer-Amirshahi and Samira Samiee-Zafarghandy and George M. Gray and Johannes N van den Anker},
  journal={American journal of obstetrics and gynecology},
  volume={211 6},
OBJECTIVE Over the past decades, there have been significant efforts in the United States to improve pharmaceutical labeling pertaining to pregnancy. The goal of this study was to describe trends in pregnancy labeling at the time of drug approval and over time. STUDY DESIGN The labeling data of 213 new pharmaceutical approvals between January 2003 and December 2012 were systematically reviewed. Initial approval data and subsequent labeling revisions were evaluated for pregnancy category… CONTINUE READING
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