FDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS
FOOD AND DRUG ADMINISTRATION
CENTER FOR DRUG EVALUATION AND RESEARCH
OFFICE OF TRANSLATIONAL SCIENCE
OFFICE OF BIOSTATISTICS
DIVISION OF BIOMETRICS I
Effective Date: 05/09/2006
1. DIVISION OF BIOMETRICS I (DBNGBA).
A. Provides comprehensive statistical and computational services to the Office of Drug Evaluation I (ODEI) (Includes the Division of Cardiovascular and Renal Products, the Division of Neurology Products, and the Division of Psychiatry Products). Performs original statistical analysis. Reviews data and analysis submitted by regulated industries for accuracy and appropriateness.
B. Conducts research and development in statistical, biomathematical, computational and other scientific decision-making methodologies.
C. Develops statistical methodologies for analyzing clinical, preclinical and epidemiological data and collaborates with other Center components on such methodologies.
D. Develops, maintains and operates, in coordination with other Center components, computer software related to these activities.
2. AUTHORITY AND EFFECTIVE DATE.
The functional statements for this Division were approved by the Director, Center for Drug Evaluation and Research effective May 9, 2006.
|STATUS (I, R, C)||DATE APPROVED||LOCATION OF CHANGE HISTORY||CONTACT||APPROVING OFFICIAL|
|Initial||05/09/2006||N/a||OC/OO/OM/OMP||Steven Galson, Director, Center for Drug Evaluation and Research|