FDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS
FOOD AND DRUG ADMINISTRATION
CENTER FOR DRUG EVALUATION AND RESEARCH
OFFICE OF PLANNING AND INFORMATICS
OFFICE OF BUSINESS INFORMATICS
DIVISION OF REGULATORY REVIEW SUPPORT
Effective Date: 03/02/2010
1. DIVISION OF REGULATORY REVIEW SUPPORT (DBNTBC).
A. Develops and conducts training programs for review and support personnel targeting the electronic submission and review process.
B. Provides business-related training for IT systems.
C. Interacts with applicants, sponsors and Center for Drug Evaluation and Research (CDER) personnel to provide accurate and timely guidance on electronic submission issues.
D. Works with organizational units within the Center to help identify and address local computing requirements.
E. Supports development of guidance and regulations associated with information management issues.
2. AUTHORITY AND EFFECTIVE DATE.
The functional statements for this office were approved by the Commissioner of Food and Drugs on March 2, 2010.
|STATUS (I, R, C)||DATE APPROVED||LOCATION OF CHANGE HISTORY||CONTACT||APPROVING OFFICIAL|
|Initial||03/02/2010||N/a||OC/OA/OM/OMP||Commissioner of Food and Drugs|