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U.S. Department of Health and Human Services

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SMG 1266.111

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 MEDICAL POLICY

OFFICE OF PRESCRIPTION DRUG PROMOTION

DIVISION OF CONSUMER DRUG PROMOTION

Effective Date: 07/08/2011

[PDF Version]

1. DIVISION OF CONSUMER DRUG PROMOTION (DKKNFAA)

A. Reviews draft Consumer Drug Promotion promotional materials and provides detailed written advisory comments to industry sponsors. Examples of draft materials include television ads, magazine ads, internet websites, and patient brochures

B. Develops and issues enforcement actions against false and misleading Consumer Drug Promotion promotional materials and activities for prescription drugs

2. AUTHORITY AND EFFECTIVE DATE

The functional statements for this Division were approved by the Secretary, Health and Human Services on July 08, 2011.

STATUS
(I, R, C)
DATE APPROVED LOCATION
OF CHANGE HISTORY
CONTACT APPROVING OFFICIAL
Initial 07/26/2011 N/a CDER/OM Director, Center for Drug Evaluation and Research
Revision 07/08/2011 N/a CDER/OM Secretary of the Department
of Health and Human Services