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 HUMAN TISSUES
Effective Date: 07/08/2011
1. DIVISION OF HUMAN TISSUES (DKKBLC).
A. Develops, maintains and administers CBER's Human Tissue Program.
B. Assists in evaluating the adequacy of directions for use, warning, and other information in labeling for tissues regulated by the Office. Evaluates adverse reactions reported in association with the use of tissues.
C. Develops policies and procedures applicable to the review and evaluation of tissues regulated by the Office.
D. Performs consultative reviews of tissue information and data in BLAs, BLA amendments, and INDs in response to request from other Center components.
E. Assesses consultative clinical reviews of tissues performed by other Centers for consistency with the CBER policies and practices.
F. Serves as the Office resource for evaluation of data obtained through the CBER inspections.
G. Provides expert scientific, medical, and technical advice and assistance to other Center components and to the Agency on tissues and related issues.
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.