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US Capitol Capsule: FDA equalises premarket, postapproval safety activities

This article was originally published in Scrip

Executive Summary

The US FDA said it now dedicates equal time and the same priority to safety for drugs postapproval as it does during a medicine's premarket review process – insisting the agency has beefed up and modernised its postmarketing surveillance process in recent years through the use of new tools and enhanced capabilities for tracking, detecting, monitoring and managing safety issues.

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