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

Короткий зміст

The Food and Drug Administration (FDA) is announcing the 1998 meetings of its clinical hold oversight committee, which reviews the clinical hold orders that the Center for Biologics Evaluation and Research (CBER) has placed on certain investigational biological product trials. For each meeting, FDA is inviting any interested biological product company to use this confidential mechanism to submit to the committee for its review the name and number of any investigational biological product trial placed on clinical hold during the past 12 months that the company wants the committee to review. DATES: The next meetings will be held on February 10, 1998; May 12, 1998; August 11, 1998; and November 10, 1998. Biological product companies may submit review requests for the February meeting by January 12, 1998; for the May meeting by March 31, 1998; for the August meeting by June 30, 1998; and for the November meeting by September 29, 1998.