Memo From Helen Winkle: Reorganization of Office of Generic Drugs

Source: PharmaManufacturing.com

Aug 03, 2011

The Office of Generics Drugs (OGD) has been reorganized to improve coordination, communication, efficiency and to enhance the Office’s ability to assure that all generic drugs are safe, effective, high quality and interchangeable to the brand name drug product/reference listed drug. The organization adds another Division to both the Bioequivalence and Chemistry programs, and converts the Microbiology and Clinical Review Staffs into Divisions.  It also formalizes the position of Deputy Director for Science and Chemistry.  Here is the new structure.
 
OFFICE OF GENERIC DRUGS
Division of Bioequivalence I
Division of Bioequivalence II
Division of Labeling and Program Support
Division of Microbiology
Division of Clinical Review
Division of Chemistry I
Division of Chemistry II
Division of Chemistry III
Division of Chemistry IV
 
The reorganization is a major step in CDER's efforts to advance the public health as the use of generic drugs continues to increase.
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