US FDA’s Remote Assessments Pose Risks For Drug Manufacturers

 
• By Sue Sutter

Information shared through a remote interactive evaluation or records request could create 'fact traps' for companies during subsequent discussions with the agency, and there’s a chance the data could be misunderstood; also, it remains to be seen if findings from remote evaluations could support civil or criminal proceedings, lawyers and consultants tell a FDLI conference.

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FDA remote evaluation tools may be viewed as a double-edged sword, allowing preapproval compliance assessments to keep flowing during COVID but also posing risks to sponsors. • Source: Shutterstock

The Food and Drug Administration’s evolving use of remote regulatory assessments and other alternatives to on-site visits maximizes the agency's inspectional footprint but can create risks for regulated companies, lawyers and consultants said.

These risks include the chance that the agency will misunderstand the data or information provided without an opportunity for the...

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