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CBER Warning Letter Pilot, Other Device Initiatives Recommended

This article was originally published in The Gray Sheet

Executive Summary

FDA's Center for Biologics Evaluation and Research should adopt the Center for Device and Radiological Health's warning letter pilot program for non-blood related devices, Gen-Probe Senior Director of Regulatory Affairs Glen Freiberg told an Oct. 6 session of the Regulatory Affairs Professionals Society annual meeting in Washington, D.C.

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