Drug Safety in Pregnancy: Review of Study Approaches Requested by Regulatory Agencies
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Purpose of Review
We reviewed postauthorization pregnancy safety studies requested by regulatory agencies to explore which study approaches have been typically requested and to what extent these have changed over time.
The most common study approach requested by the US Food and Drug Administration (FDA) is pregnancy exposure registries (observational cohorts with prospective data collection), per the FDA’s Postmarketing Requirements and Commitments (PMR/PMC) database. Since 2017, this requirement has often been paired with a request for a database study (observational study using preexisting electronic health care data), both approaches assessing pregnancy and fetal outcomes. From studies registered in the European Union electronic Register of Post-Authorisation Studies, we observed a similar number of pregnancy exposure registries and database studies, both approaches also assessing pregnancy and fetal outcomes. In requests for drugs approved since 2014, preference appears to have shifted toward studies using preexisting electronic health care databases from multiple countries.
Pregnancy exposure registries have been the most commonly requested study approach on drug safety in pregnancy. Recent regulatory requests and activities denote an increasing interest in other approaches.
KeywordsPostauthorization safety studies PASS Regulatory requirements Pregnancy pharmacoepidemiology Pregnancy exposure registries Pregnancy registries
Editorial services were provided by John Forbes and graphic design support was provided by Jason Mathes and Christopher Lovett, all employees of RTI Health Solutions. The authors thank Abenah Harding and Catherine Saltus, also from RTI Health Solutions, for their help in the preparation of this manuscript.
This project was funded by RTI Health Solutions.
Compliance with Ethical Standards
Conflict of Interest
The authors declare that they have no conflicts of interest.
Human and Animal Rights
This article does not contain any studies with human or animal subjects performed by any of the authors.
Papers of particular interest, published recently, have been highlighted as: • Of importance •• Of major importance
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