SMG 1266.121

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

DIVISION OF MEDICAL POLICY DEVELOPMENT

Effective Date: 07/26/2011

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1. DIVISION OF MEDICAL POLICY DEVELOPMENT (DNFBA).

A. Directly responsible for the development of medical policy pertaining to the drug development, drug approval, bioresearch monitoring, human subject protection and post market surveillance processes in collaboration with appropriate program areas and coordinating committees. Develops issue papers, guidances, regulations, and operating procedures

B. Provides advice and assistance to FDA staff and external constituents concerning implementation or application of new and existing medical policies and procedures

C. Collaborates with the Office of Regulatory Policy to ensure timely and efficient clearance and dissemination of new and revised policy documents

2. AUTHORITY AND EFFECTIVE DATE.

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