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U.S. Department of Health and Human Services

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SMG 1266.112

FDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS

FOOD AND DRUG ADMINISTRATION

CENTER FOR DRUG EVALUATION AND RESEARCH

OFFICE OF MEDICAL POLICY

OFFICE OF PRESCRIPTION DRUG PROMOTION

DIVISION OF PROFESSIONAL PROMOTION

Effective Date: 07/26/2011

[PDF Version]

1. DIVISION OF PROFESSIONAL PROMOTION (DNFAB).

A. Reviews draft promotional materials directed to healthcare professionals and provides detailed written advisory comments to industry sponsors. Examples of draft materials include journal ads, internet websites, commercial exhibit hall materials, sales aids, and broadcast advertisements

B. Develops and issues enforcement actions against false and misleading prescription drug promotional materials and activities directed to healthcare professionals

C. Reviews draft professional labeling for inappropriate promotional content

2. AUTHORITY AND EFFECTIVE DATE.

The functional statements for this Division were approved by the Secretary, Health and Human Services on July 26, 2011.

STATUS (I, R, C)DATE APPROVEDLOCATION OF CHANGE HISTORYCONTACTAPPROVING OFFICIAL
Initial07/26/2011N/aCDER/OMSecretary, Health and Human Services
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