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CDER - Organization - Text version

The following header reflects the organizational hierarchy.

Food and Drug Administration
Office of Medical Products and Tobacco
Center for Drug Evaluation and Research


The following is the communication box containing information to assist anyone who may want to
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The following is the Food and Drug Administration, Office of Medical Products and Tobacco, Center for Drug Evaluation and Research organization structure depicting all the organizational structures reporting to the Office Director. These organizational structures are organized in sequential order by their assigned Standard Administrative code (Alphanumeric sequence of characters beginning with the letter D).

Each organizational component will be depicted in the following standard format:

Title of Organization
Position title of the manager
Military rank if any, first name, middle initial if any, last name, post graduate degrees
if any, and if the individual is designated as acting
Standard Administrative Code


Director
Janet Woodcock, M.D.
(DKKNA)

Reports directly to the Center Director:

Office of Regulatory Policy
Director
Grail Sipes, J.D.
(DKKNAA)

Office of Management
Director
Melanie Keller, M.B.A.
(DKKNB)

Office of Communications          
Director
Christine Shreeve, M.A.
(DKKNC)

Office of Compliance
Director
Donald D. Ashley, J.D.
(DKKND)

Reports directly to the Office Director: 

Office of Manufacturing Quality
Director
Thomas Cosgrove, J.D.
(DKKNDA)

Office of Unapproved Drugs and Labeling Compliance
Director
Carolyn Becker
(DKKNDD)

Office of Scientific Investigations
Director
Vacant
(DKKNDE)

Office of Drug Security, Integrity, and Response
Director
Thomas J. Christl
(DKKNDF)

Office of Program and Regulatory Operations
Director
Maria Rossana Cook
(DKKNDG)

Reports directly to the Center Director:

Office of Medical Policy
Director
Jacqueline Corrigan-Curay, J.D., M.D.
(DKKNF)

Reports directly to the Office Director: 

Office of Prescription Drug Promotion
Director
Thomas W. Abrams
(DKKNFA)

Office of Medical Policy Initiatives
Director
Vacant 
(DKKNFB)

Reports directly to the Center Director:

Office of Translational Sciences
Director
ShaAvhree Buckman-Garner, M.D., Ph.D., F.A.A.P.
(DKKNG)

Reports directly to the Office Director:

Office of Biostatistics
Director
Lisa LaVange, Ph.D.
(DKKNGB)

Office of Clinical Pharmacology
Director
Issam Zineh, Pharm.D., M.Ph., F.C.C.P.
(DKKNGC)

Office of Computational Science
Director
Lilliam Rosario, Ph.D.
(DKKNGD)

Office of Study Integrity and Surveillance
Director
Sean Kassim, Ph.D.
(DKKNGE)


Reports directly to the Center Director:

Office of Executive Programs
Director
Mary Beth Clarke
(DKKNH)

Reports directly to the Center Director:

Office of Surveillance and Epidemiology
Director
Gerald J. Dal Pan, M.D., M.H.S.
(DKKNO)

Reports directly to the Office Director:

Office of Medication Error Prevention and Risk Management
Director
Claudia Manzo, Pharm.D.
(DKKNOG)

Office of Pharmacovigilance and Epidemiology
Director
Judith Zander, M.D.
(DKKNOH)

Reports directly to the Center Director:

Office of New Drugs
Director
Vacant
(DKKNR)

Reports directly to the Office Director:

Office of Drug Evaluation I
Director
Ellis Unger, M.D.
(DKKNRA)

Office of Drug Evaluation II
Director
Curtis Rosebraugh, M.D.
(DKKNRB)

Office of Drug Evaluation III
Director
Julie G. Beitz, M.D.
(DKKNRC)

Office of Antimicrobial Products
Director
Edward M. Cox, M.D., M.P.H.
(DKKNRD)

Office of Drug Evaluation IV
Director
Charles J. Ganley, M.D.
(DKKNRE)

Office of Hematology and Oncology Products
Director
Vacant
(DKKNRM)

Reports directly to the Center Director:

Office of Strategic Programs
Director
Theresa Mullin, Ph.D.
(DKKNT)

Reports directly to the Office Director:

Office of Program and Strategic Analysis
Director
Vacant
(DKKNTA)


Office of Business Informatics
Director
Hilmar Hamann, Ph.D.
(DKKNTB)

Reports directly to the Center Director:

Office of Generic Drugs
Director
Kathleen Uhl, M.D.
(DKKNU)

Reports directly to the Office Director:

Office of Research Standards
Director
Robert Lionberger, Ph.D.
(DKKNUA)

Office of Bioequivalence
Dale Conner, Pharm.D.
(DKKNUB)

Office of Generic Drug Policy
Director
Keith Flanagan, J.D.
(DKKNUC)

Office of Regulatory Operations
Director
Edward (Ted) Sherwood
(DKKNUD)

Reports directly to the Center Director:

Office of Pharmaceutical Quality
Director
Michael Kopcha, Ph.D.
(DKKNV)

Reports directly to the Office Director:

Office of Biotechnology Products
Director
Steven Kozlowski, M.D.
(DKKNVA)

Office of New Drug Products
Director
Sarah Pope Miksinski, Ph.D.
(DKKNVB)

Office of Policy for Pharmaceutical Quality
Director
Ashley Boam, B.S.E. & M.S.B.E.
(DKKNVC)

Office of Process and Facilities
Director
Robert Iser, M.S.
(DKKNVD)

Office of Surveillance
Director
Vacant
(DKKNVE)

Office of Testing and Research
Director
Lucinda Buhse, Ph.D.
(DKKNVF)

Office of Program and Regulatory Operations
Director
Giuseppe Randazzo
(DKKNVG)

Office of Lifecycle Drug Products
Director
Susan Rosencrance
(DKKNVH)

Approved by the FDA Reorganization Coordinator and Principal Delegations Control Officer

Page Last Updated: 09/19/2017
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