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Zdrowie i gospodarka · 21.03.2001

Draft Guidance for Industry: Disclosing Information Provided to Advisory Committees in Connection With Open Advisory Committee Meetings Related to the Testing or Approval of Biologic Products and Convened by the Center for Biologics Evaluation and Research; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled "Guidance for Industry: Disclosing Information Provided to Advisory Committees in Connection With Open Advisory Committee Meetings Related to the Testing or Approval of Biologic Products and Convened by the Center for Biologics Evaluation and Research" dated February 2001. This document, when finalized, is intended to provide guidance to sponsors of applications that are the subject of an open advisory committee meeting convened by the Center for Biologics Evaluation and Research (CBER), beginning on June 1, 2001. The draft guidance document provides procedures that will be adopted by CBER for making information provided to advisory committee members in connection with such meetings publicly available. The draft guidance document also describes how a sponsor should prepare its submission to an advisory committee.

Source: Federal Register — Food and Drug AdministrationOpen original release →