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U.S. Department of Health and Human Services

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SMG 1266.12

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 MEDICAL POLICY INITIATIVES

Effective Date: 07/26/2011

[PDF Version]

1. OFFICE OF MEDICAL POLICY INITIATIVES (DNFB).

Provides oversight and direction for development of medical policies and procedures pertaining to the drug development and drug approval, and post market surveillance processes

Provides oversight and direction for new and ongoing policy initiatives in broad-based medical and clinical policy areas, including initiatives to develop active safety monitoring of marketed products, improve the science and efficiency of clinical trials, regulate biosimilars (or follow-on biologics), and enhance consumer-directed drug information

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
Initial07/26/2011N/aCDER/OMSecretary, Health and Human Services