FDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS
FOOD AND DRUG ADMINISTRATION
OFFICE OF MEDICAL PRODUCTS AND TOBACCO
CENTER FOR BIOLOGICS EVALUATION AND RESEARCH
OFFICE OF VACCINES RESEARCH AND REVIEW
DIVISION OF BACTERIAL, PARASITIC AND ALLERGENIC PRODUCTS
Effective Date: 07/08/2011
1. DIVISION OF BACTERIAL, PARASITIC AND ALLERGENIC PRODUCTS (DKKBFA).
A. Plans and conducts scientific research related to the microbiology, pathogenesis, and immunology of bacterial and parasitic diseases in humans and the biochemistry and immunology of allergenic products.
B. Develops specialized biochemical and biophysical laboratory and clinical methodologies for application to the standardization and control of bacterial, parasitic, and allergenic products; evaluates clinical experience and reports of adverse reaction events.
C. Reviews, evaluates, and takes appropriate actions, in coordination with other Center components, on investigational new drug applications (INDs), biologics license applications (BLAs), and BLA supplements. Develops policy and formulates decisions on INDs and BLAs for bacterial, parasitic, and allergenic and related biological products.
D. Reviews INDs and BLAs for combinations of new and licensed vaccines and related biological products. Interacts with other Center components on policy decisions regarding combination products
E. Performs laboratory tests and reviews manufacturers' protocols on bacterial, parasitic, allergenic and related biological products submitted in support of INDs and BLAs. Performs specific laboratory tests and reviews manufacterers' protocols for lot release of licensed bacterial, parasitic, and standardized allergenic products.
F. Participates in the inspection of manufacturers of licensed bacterial, parasitic and allergenic products, manufacturing facilities, and products pending licensure.
G. Reviews product labeling and promotional materials for adequacy of directions for use, warning, and other information for products regulated by the Division.
H. Assists in collaborative research and management of contract-supported activities.
I. Provides expert scientific and technical advice and assistance to other Agency components, PHS agencies, advisory committees, and international and academic organizations on issues related to the safety and efficacy of bacterial, parasitic, and allergenic products.
2. AUTHORITY AND EFFECTIVE DATE.
The functional statements for this Division were approved by the Secretary of the Department of Health and Juman Services on July 8, 2011.