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 CELLULAR, TISSUE AND GENE THERAPIES
DIVISION OF CELLULAR AND GENE THERAPIES
Effective Date: 07/08/2011
1. DIVISION OF CELLULAR AND GENE THERAPIES (DKKBLA).
A. Evaluates Biologic License Applications (BLAs) and amendments to BLAs for cellular, tissue engineering and gene therapy products. Directs BLA review committee activities. Formulates recommendations on approvability for marketing of cellular, tissue engineering and gene therapy products and develops policy and formulates decisions on BLA amendments.
B. Reviews investigational new drug applications (INDs), investigational devise exemptions (IDEs), 510Ks and PMAs for new cellular, tissue engineering and gene therapy products.
C. Assists in evaluating the adequacy of directions for use, warning, and other information in proposed labeling for products regulated by the Office. Evaluates adverse reactions reported in association with the use of marketed cellular and gene therapy products.
D. Participates in the inspection of manufacturers of cellular, tissue engineering and gene therapy products. Tests certain cellular, tissue engineering and gene therapy products submitted for release and reviews manufacturers protocols with respect to such tests.
E. Serves as a resource to the Center for the review of BLAs related to cellular, tissue engineering and gene therapy products.
F. Provides expert scientific, medical, and technical advice and assistance to other Center components and to the Agency on cellular, tissue engineering and gene therapy products and related issues.
G. Develops policies and procedures applicable to the review and evaluation of INDs, IDEs, 510Ks, PMAs, BLAs and products regulated by the Office.
H. Performs consultative reviews of product information and data in BLAs, BLA amendments, and INDs IDEs, 510Ks, PMAs in response to request from other Center components.
I. Assesses consultative product reviews of biological products performed by other Centers for consistency with the CBER policies and practices.
J. Serves as the Office resource for evaluation of clinical data obtained through the CBER inspections and bioresearch monitoring program.
K. Evaluates and conducts scientific research on molecular and cellular biology related to products regulated by the office using both laboratory and clinical procedures.
L. Evaluates and conducts scientific research on tumor biology, virology and immunology and cell biology related to cellular, tissue engineering and gene therapy and related products using both laboratory and clinical procedures.
M. Assists in collaborative research and management of contract-supported activities.
2. AUTHORITY AND EFFECTIVE DATE.
The functional statements for this Division were approved by the Secretary of the Department of Health and Human Services on
July 8, 2011.