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 CLINICAL EVALUATION AND PHARMACOLOGY/TOXICOLOGY
Effective Date: 07/08/2011
1. DIVISION OF CLINICAL EVALUATION AND PHARMACOLOGY/TOXICOLOGY (DKKBLB).
A. Develops and maintains the Office's Clinical Review Program.
B. Evaluates for safety and efficacy pharmacologic, toxicologic, and clinical data submitted in support of biologic license applications (BLAs) and of amendments to BLAs. Decides on the adequacy of preclinical and clinical trial design and data submitted to support licensure and license amendments.
C. Evaluates for safety and appropriateness the design of proposed and ongoing clinical trials performed under IND. Evaluate the safety and efficacy preclinical and clinical data submitted in support of investigational new drug applications (INDs).
D. 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.
E. Serves as a resource to the Center for the review of BLAs related to cellular, tissue and gene therapy products.
F. Develops policies and procedures applicable to the review and evaluation of INDs, BLAs and products regulated by the Office.
G. Performs consultative reviews of preclinical and clinical trial design and data in BLAs, BLA amendments, and INDs in response to request from other Center components.
H. Develops and pursues research programs in clinical trial methodology and analysis and pharmacology/toxicology.
I. Assesses consultative clinical 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.
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.