Draft Guidance for Industry on Monoclonal Antibodies Used as Reagents in Drug Manufacturing; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Monoclonal Antibodies Used as Reagents in Drug Manufacturing.'' This draft guidance provides recommendations to sponsors and applicants on the information that should be included in investigational new drug applications (IND's), new drug applications (NDA's), abbreviated new drug applications (ANDA's), biologics license applications (BLA's), and supplements to these applications when monoclonal antibodies are used as reagents in the manufacture of drug substances and drug products that are regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).