SMG 1262.1

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 COMPLIANCE

Effective Date: 07/08/2011

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1. OFFICE OF COMPLIANCE (DKKND)

A. Promotes and protects the public health through strategies and actions that minimize consumer exposure to unsafe, ineffective, and poor quality drugs

B. Proactively advises the Center Director and other Agency officials on FDA’s regulatory and enforcement responsibilities and possible risks associated with human drugs, application integrity, and human subject protection

C. Strategically implements programs and projects to identify, assess, and prioritize the public health significance of legal violations presented throughout the drug lifecycle

D. Develops and utilizes innovative enforcement strategies and risk-based decision making to reduce public health risk by ensuring that marketed drugs are of high quality and integrity, properly labeled, safe, pure, and meet applicable drug approval requirements

E. Coordinates Center-field relations and provides support and guidance to field offices on case development and regulatory actions, and ensures uniform

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	05/09/2006	N/a	OC/OO/ OM/OMP	Steven Galson, Director, Center for Drug Evaluation and Research
Revision	05/20/2011	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