Investigational New Drugs; 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 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. The experimental phase of the committee process has concluded, and FDA has decided that the committee will now meet semiannually as a regular program. 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.