SMG 1261.57

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 MEDICATION ERROR PREVENTION AND RISK MANAGEMENT

Effective Date: 07/08/2011

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1. OFFICE OF MEDICATION ERROR PREVENTION AND RISK MANAGEMENT (DKKNOG)

A. Directs and supports the Divisions of Medication Error Prevention and Analysis and Risk Management

B. Leads Office of Surveillance and Epidemiology review of proposed and implemented Risk Minimization Action Plans (RiskMAPs)/Risk Evaluation and Mitigation Strategies (REMS)

C. Coordinates risk communication components of drug safety risk management programs

D. Coordinates reviews of proposed proprietary trade names for their potential to result in sound-alike or look-alike medication errors

E. Performs root-cause analyses of post-marketing medication error reports

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