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In Brief: CBER clinical holds

Executive Summary

CBER clinical holds: Center for Biologics Evaluation & Research will hold a meeting of the clinical hold review committee in February. FDA invites biological product companies to submit to the committee the name and number of any investigational biological product trial placed on clinical hold during the past 12 months that the company wants reviewed. Review requests should be submitted to FDA Chief Mediator and Ombudsman Amanda Pederson by Jan. 30, according to a Jan. 11 Federal Register notice...



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