• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

About FDA

  • Print
  • Share
  • E-mail

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 Food and Drug Administration’s, 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
Cynthia Schnedar, J.D.
(DKKND)

Reports directly to the Office Director: 

Office of Manufacturing Quality
Director
Thomas Cosgrove
(DKKNDA)

Office of Unapproved Drugs and Labeling Compliance
Director
Vacant
(DKKNDD)

Office of Science Investigations
Director
Sean Kassim
(DKKNDE)

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

Office of Program and Regulatory Operations
Director
Vacant
(DKKNDG)

Reports directly to the Center Director:

Office of Medical Policy
Director
Vacant
(DKKNF)

Reports directly to the Office Director: 

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

Office of Medical Policy Initiatives
Director
CAPT Richardae Araojo
(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
Vacant
(DKKNGD)

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
Vacant
(DKKNOG)

Office of Pharmacovigilance and Epidemiology
Director
Solomon Iyasu, M.D., M.Ph.
(DKKNOH)

Reports directly to the Center Director:

Office of New Drugs
Director
John Jenkins, M.D.
(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.Ph.
(DKKNRD)

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

Office of Hematology and Oncology Products
Director
Richard Pazdur, M.D.
(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
Patrick Frey, M.P.P.
(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
Vacant
(DKKNUB)

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

Office of Regulatory Operations
Director
Vacant
(DKKNUD)

Reports directly to the Center Director:

Office of Pharmaceutical Quality
Director
Vacant
(DKKNV)

Reports directly to the Office Director:

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

Office of New Drug Products
Director
Vacant
(DKKNVB)

Office of Policy for Pharmaceutical Quality
Director
Vacant
(DKKNVC)

Office of Process and Facilities
Director
Vacant
(DKKNVD)

Office of Surveillance
Director
Vacant
(DKKNVE)

Office of Testing and Research
Director
Vacant
(DKKNVF)

Office of Program and Regulatory Operations
Director
Vacant
(DKKNVG)

Office of Lifecycle Drug Products
Director
Vacant
(DKKNVH)

Approved by the FDA Reorganization Coordinator and Principal Delegations Control Officer

 
-