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

摘要

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 Drug Evaluation and Research (CDER) has placed on certain investigational new drug trials. The committee was established as a 1-year experiment in August 1991. The committee met quarterly through 1992 and currently meets semiannually as a regular program. The committee last met in April 1994. FDA is inviting any interested drug company to use the confidential mechanism to submit to the committee for its review the name and number of any investigational new drug trial placed on clinical hold during the past 12 months that the company wants the committee to review.