Investigational New Biological Product Trials; Procedure to Monitor Clinical Hold Process; Meeting of Review Committee and Request for Submissions

Resumo

The Food and Drug Administration (FDA) is announcing a meeting of the clinical hold review committee, which reviews the clinical holds that the Center for Biologics Evaluation and Research (CBER) has placed on certain investigational new biological product trials. CBER held its first clinical hold review committee meeting on May 17, 1995. FDA is inviting any interested biological company to use this confidential mechanism to submit to the committee for its review the name and number of any investigational new biological products trial placed on clinical hold during the past 12 months that the company wants the committee to review.