Postapproval Pregnancy Safety Studies
The FDA issued guidance providing recommendations for sponsors and investigators on designing postapproval investigations to assess outcomes in pregnant women exposed to drug and biological products.
Sponsors and investigators of FDA-regulated drug and biological products conducting post-market safety assessments for pregnant populations.
Standardizing the methodology for pregnancy safety studies is critical for generating reliable data in a historically understudied population. This guidance suggests an increased regulatory focus on structured post-market data collection, which may influence how sponsors plan their Phase IV commitments and safety surveillance frameworks for products likely to be used by women of reproductive age.
Regulatory and clinical teams should review current postapproval study designs against these recommendations to ensure methodologies for capturing pregnancy outcomes meet FDA expectations. Quality and PV teams may need to update protocols for data collection and assessment of exposure during pregnancy.
This guidance provides sponsors and investigators with recommendations on how to design investigations to assess the outcomes in pregnant women exposed to drug and biological products regulated by FDA in the postapproval setting.
Open in openFDA / FDA.gov