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 guidance for industry entitled "Monoclonal Antibodies Used as Reagents in Drug Manufacturing." This guidance is intended to provide recommendations for sponsors and applicants of new drug applications (NDA's), abbreviated new drug applications (ANDA's), biologics license applications (BLA's), their supplements, or investigational new drug applications (IND's) on information that should be included in applications when monoclonal antibodies (mAb's) are used as reagents in the manufacture of drug substances regulated by the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER).