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 BIOSTATISTICS AND EPIDEMIOLOGY
Effective Date: July 8, 2011
1. OFFICE OF BIOSTATISTICS AND EPIDEMIOLOGY (DKKBJ).
A. Provides comprehensive statistical and epidemiological evaluation of data submitted to the Center in support of regulatory requirements.
B. Collaborates with other Center components to provide reviews and assessments of regulated biological products.
C. Represents the Center within the agency, the Public Health Service, the Department and elsewhere regarding initiatives relating to the statistical and/or epidemiological evaluation of medical products, including the evaluation of product safety.
D. Contributes to the development of regulatory policy in areas relevant to the disciplines of biostatistics and epidemiology, such as post-marketing surveillance and the design, conduct and analysis of studies to evaluate medical products.
E. Conducts independent research relating to statistical and epidemiological methods for assessing the efficacy and safety of biological products, and for assuring the quality and consistency of their manufacture.
2. AUTHORITY AND EFFECTIVE DATE.
The functional statements for this Office were approved by the Secretary of Health and Human Services on July 8, 2011.
|STATUS (I, R, C)||DATE APPROVED||LOCATION OF CHANGE HISTORY||CONTACT||APPROVING OFFICIAL|
|Initial||11/5/1999||N/A||OC/OO/OM/OMP||Commissioner of Food and Drugs|
|Revision||07/08/2011||N/A||OMPT/CBER/OM||Secretary of Health and Human Services|