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.