Guidance for Industry on Advisory Committees: Implementing Section 120 of the Food and Drug Administration Modernization Act of 1997; Availability

Краткое содержание

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Advisory Committees: Implementing Section 120 of the Food and Drug Administration Modernization Act of 1997.'' This document provides guidance for industry on changes to the policies and procedures being used by the Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) with regard to advisory committees as a result of section 120 of the Food and Drug Administration Modernization Act of 1997 (the Modernization Act).