SMG 1261.58

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

Effective Date: 07/08/2011

[PDF Version]

1. OFFICE OF PHARMACOVIGILANCE AND EPIDEMIOLOGY (DKKNOH)

A. Directs and supports the Divisions of Pharmacovigilance and Epidemiology

B. Evaluates the safety of marketed drugs

C. Reviews adverse event reports with the Office of New Drugs

D. Collaborates with other offices to recommend appropriate actions

E. Provides recommendations on risk management programs and REMS

F. Coordinates the review and analysis 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

2. AUTHORITY AND EFFECTIVE DATE

The functional statements for this Office 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	03/03/2010	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