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FDA forming task force to develop proposals for third-party certification.

This article was originally published in The Rose Sheet

Executive Summary

FDA THIRD-PARTY CERTIFICATION EFFORT will focus initially on the agency's enforcement program as it seeks to identify activities that can be shifted to outside organizations, accord-ing to agency staffers. FDA is forming a task force to develop proposals for use of third-party certification; the group is headed up by the Office of Regulatory Affairs Enforcement Office, and will include representatives from each of FDA's five centers. Enforcement activities considered likely candidates for third-party certification include reinspections of violative firms and inspections of overseas manufacturers. FDAers note that while the task force initially will look at the agency's enforcement programs, the use of third parties in other areas such as premarket review also will be considered.
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