SMG 1261.582

FDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS

FOOD AND DRUG ADMINISTRATION

OFFICE OF MEDICAL PRODUCTS AND TOBACCO

CENTER FOR DRUG EVALUATION AND RESEARCH

OFFICE OF SURVEILLANCE AND EPIDEMIOLOGY

OFFICE OF PHARMACOVIGILANCE AND EPIDEMIOLOGY

DIVISION OF EPIDEMIOLOGY II

Effective Date: 07/08/2011

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1. DIVISION OF EPIDEMIOLOGY II (DKKNOHB)

A. Provides leadership, direction, planning, budgeting, management and supervision of Division programs and staff

B. Reviews and analyses of epidemiologic study protocols and results of epidemiologic studies submitted by industry, from the literature or other sources that are related to the postmarketing safety of drugs

C. Provides development and assessment of methodologies and best practices for scientifically-sound observational studies related to the postmarketing safety of drugs

D. Reviews and analyses of drug utilization information

E. Performs epidemiologic research on drug safety issues

F. Provides epidemiologic and drug utilization expertise to support medical review Divisions in areas of responsibility, as well as, for Advisory Committee presentations and related documents

G. Provides input on epidemiologic and drug utilization aspects of information for the public related to significant post-marketing safety information regarding drugs, biologics, devices and foods

H. Develops and implements internal Manuals of Policies and Procedures (MAPPs) and guidance on epidemiologic and drug utilization initiatives

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.

STATUS (I, R, C)	DATE APPROVED	LOCATION OF CHANGE HISTORY	CONTACT	APPROVING OFFICIAL
Initial	03/03/2011	N/a	CDER/OM	Commissioner of Food and Drugs
Revision	07/08/2011	N/a	CDER/OM	Secretary of the Department of Health and Human Services