Sentinel Could Be Used For Pregnancy Safety Studies Under PDUFA VII

User fee program inflation adjustment also proposed to be changed to account for only PDUFA-related personnel.

Sentinel Sign
Industry and the FDA are considering several health care outcomes of interest to study using the Sentinel system. • Source: Shutterstock

The Sentinel surveillance system could grow to study drug safety during pregnancy and other health outcomes as part of the prescription drug user fee reauthorization.

The US Food and Drug Administration has proposed including pregnancy safety as a health outcome of interest to be studied using Sentinel, the agency’s safety system that uses insurance claims, electronic medical records and other data to spot potential signals. In recently released

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