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FDA Guidance for Industry Monoclonal Antibodies Used as Reagents in Drug Manufacturing


Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA,

Document Type:
Guidance for Industry
This guidance is intended to provide recommendations to sponsors and applicants on the use of monoclonal antibodies(mAbs) as reagents in the manufacture of drug substances 2 that are regulated by the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research(CBER). The guidance focuses on the chemistry, manufacturing, and control (CMC) issues that should be addressed in new drug applications(NDAs), abbreviated new drug applications (ANDAs), biologics license applications(BLAs), supplements to these applications, or investigational new drug applications (INDs).

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