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 THERAPEUTIC PROTEINS
Effective Date: 10/01/2003
1. DIVISION OF THERAPEUTIC PROTEINS (DBNSEB).
A. Evaluates and conducts scientific research in the areas of immunology, biochemistry, and chemistry, required for regulation of therapeutic biological products.
B. Evaluates biological license applications (BLAs) and amendments to BLAs for therapeutic biologic products regulated by the Division. Directs BLA review committee activities. Determines approvability for marketing of products and develops policy and formulates decisions on BLA amendments.
C. Review investigational new drug applications (INDs) for products regulated by the Division.
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 proposed labeling for products regulated by the Division. Evaluates adverse reactions reported in association with the use of marketed products.
H. Participates in the inspection of manufacturers of regulated products. Evaluates testing of biologics 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.