Memo From Helen Winkle: Reorganization of Office of Generic Drugs

Aug. 3, 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 DRUGSDivision of Bioequivalence IDivision of Bioequivalence IIDivision of Labeling and Program SupportDivision of MicrobiologyDivision of Clinical ReviewDivision of Chemistry IDivision of Chemistry IIDivision of Chemistry IIIDivision of Chemistry IVThe reorganization is a major step in CDER's efforts to advance the public health as the use of generic drugs continues to increase.