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SMG 1264.61

FDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS

FOOD AND DRUG ADMINISTRATION

CENTER FOR DRUG EVALUATION AND RESEARCH

OFFICE OF PHARMACEUTICAL SCIENCE

OFFICE OF BIOTECHNOLOGY PRODUCTS

DIVISION OF MONOCLONAL ANTIBODIES

Effective Date: 10/01/2003

[PDF Version]

1. DIVISION OF MONOCLONAL ANTIBODIES (DBNSEA).

A. Evaluates and conducts scientific research related to monoclonal antibody structure and function, the regulation of antibody synthesis, the functions of radionuclide and toxin coupled monoclonal antibody therapeutics, and basic mechanisms involving the biology and physiology of cells involved in the immune system.

B. Evaluates biological product license applications (BLAs) and amendments to BLAs for monoclonal antibody products. Directs BLA review committee activities and assigned committee membership within this Office and other Center for Drug Evaluation and Research (CDER) Offices, as required. Determines approvability for marketing of monoclonal antibody products and develops policy and approvability of BLA amendments.

C. Reviews investigational new drug applications (INDs) for new monoclonal antibody products.

D. Develops policies and procedures applicable to the review and evaluation of INDs and products and their labeling regulated by the Division.

E. Participates in the Center's pharmacology, toxicology, and clinical review programs.

F. Assists in collaborative research and management of contract supported activities.

G. Assists in evaluating the adequacy of directions for use, warning, and other information in proposed labeling for products regulated by the Division. Evaluates adverse reactions reported in association with the issue of marketed monoclonal antibody products.

H. Participates in the inspection of manufacturers of monoclonal antibody products. Tests certain monoclonal antibody products submitted for release and reviews manufacturer protocols with respect to such tests.

I. Provides expert scientific, medical, and technical advice and assistance to other components of the Center and the Agency. Reviews BLAs, amendments, and INDs as part of collaborative reviews with other Centers (Center for Devices and Radiological Health, and Center for Biologics Evaluation and Research).

2. AUTHORITY AND EFFECTIVE DATE.

The functional statements for this Division were approved by the Commissioner, Food and Drug Administration effective October 1, 2003.