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
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 APPROVED||LOCATION OF CHANGE HISTORY||CONTACT||APPROVING OFFICIAL|
|Initial||05/09/2006||N/a||OC/OO/OM/OMP||Steven Galson, Director, Center for Drug Evaluation and Research|
|Revision||07/26/2011||N/a||CDER/OM||Secretary, Health and Human Services|