FDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS
FOOD AND DRUG ADMINISTRATION
OFFICE OF MEDICAL PRODUCTS AND TOBACCO
OFFICE OF OPERATIONS
CENTER FOR BIOLOGICS EVALUATION AND RESEARCH
OFFICE OF VACCINES RESEARCH AND REVIEW
DIVISION OF VIRAL PRODUCTS
Effective Date: 07/08/2011
1. DIVISION OF VIRAL PRODUCTS (DKKBFC)
A. Plans and conducts research related to the development, manufacture, and testing of vaccines. Performs research and provides expertise on viruses known or suspected to constitute contaminants of cell substrates used for manufacture of biologic.
B. Develops, in coordination with other Center components, clinical methodologies for application to viral vaccine products and immunomodulatory agents; evaluates clinical experience and reports of adverse reaction events as necessary.
C. Reviews, evaluates, and takes appropriate actions on investigational new drug applications (INDs), establishment license applications (ELAs), and product license applications (PLAs) related to viral vaccines used in the prevention of AIDS, DNA viruses, vaccines used for childhood immunizations, lots submitted for release action, and other vaccines which may come under the purview of the Division. Develops policy and formulates decisions on PLA amendments for viral and related biological products.
D. Develops and disseminates policies, procedures, guidelines, and regulations, governing the review and evaluation of viral vaccines and related products, in coordination with other Center components.
E. Performs laboratory tests and reviews manufacturers protocols on viral and related biological products submitted in support of INDs, PLAs, and ELAs.
F. Performs inspections of manufacturers of licensed products, manufacturing facilities, and products pending licensure. Performs laboratory tests and reviews manufacturing protocols for lot release of licensed vaccines.
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 research and management of contract-supported activities. Collaborates with national and international health agencies on evaluation studies of International Reference Preparations and functions as a WHO/PAHO Reference laboratory.
I. Provides expert scientific and technical advice and assistance to other Agency components, DHHS agencies, advisory committees, and international and academic organizations on issues related to immunization programs and to the safety and efficacy of vaccines.
2. AUTHORITY AND EFFECTIVE DATE.
The functional statements for this Division were approved by the Director, Center for Biologics Evaluation and Research on July 8, 2011.