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FDA Launches Voluntary Compliance Improvement Pilot

This article was originally published in The Gray Sheet

Executive Summary

The Office of Compliance pilot aims to challenge companies with less-than-stellar quality systems to improve compliance at their facilities without undergoing an inspection.

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Firms with an egregious state of quality control might be able to enter into remediation agreements with FDA; agency might ease up on direct marking of devices in final UDI rule; and more.

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Moment Of Truth For Seven EU Filings; Cytokinetics To Make Its Case For Heart Failure Drug

The CHMP, the European Medicines Agency’s human medicines committee, will this week decide whether a range of new medicines merit being approved.


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