SMG 1260.24

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 REGULATORY POLICY

DIVISION OF REGULATORY POLICY III

Effective Date: 07/08/2011

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1. DIVISION OF REGULATORY POLICY III (DKKNAAD)

A. Initiates, develops, and reviews regulations, policies, procedures and guidance’s that affect the regulation of drugs under the Federal Food, Drug, and Cosmetic Act

B. Serves as the Center’s focal point on regulatory issues providing advice and assistance on such matters as scope, applicability and meaning of the Federal Food, Drug, and Cosmetic Act, other laws, regulations, and policies

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	10/23/2008	N/a	OC/OO/ OM/OMP	Director, Center for Drug Evaluation and Research
Revision	07/08/2011	N/a	CDER/OM	Secretary of the Department of Health and Human Services