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SMG 1266.1

FDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS

FOOD AND DRUG ADMINISTRATION

CENTER FOR DRUG EVALUATION AND RESEARCH

OFFICE OF MEDICAL POLICY

Effective Date: 07/26/2011

[PDF Version]

1. OFFICE OF MEDICAL POLICY (DNF).

A. Provides Center oversight and leadership in the development of medical policy, procedures, and policy initiatives pertaining to the drug development, drug approval, bioresearch monitoring, human subject protection and post market surveillance processes

B. Provides scientific and regulatory leadership in ensuring accurate and effective communication of medical information to healthcare professionals and patients and compliance with applicable regulations

C. Fosters an interdisciplinary approach to medical policy development, implementation, and coordination through collaboration with other disciplines, program areas, and FDA Centers in a manner that enhances integration of evolving science and policy into drug development, regulatory review, and post market surveillance processes

2. AUTHORITY AND EFFECTIVE DATE.

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

STATUS (I, R, C)DATE APPROVEDLOCATION OF CHANGE HISTORYCONTACTAPPROVING OFFICIAL
Initial05/09/2006N/aOC/OO/OM/OMPSteven Galson, Director, Center for Drug Evaluation and Research
Revision07/26/2011N/aCDER/OMSecretary, Health and Human Services