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
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 APPROVED||LOCATION OF CHANGE HISTORY||CONTACT||APPROVING OFFICIAL|
|Initial||07/26/2011||N/a||CDER/OM||Secretary, Health and Human Services|