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U.S. Department of Health and Human Services

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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 communicate with the depicted organization via telephone, facsimile or mail.

Main Tel:
301-796-5400
Fax:
301-595-7910
Address:
WO Bldg 51 Rm: 6133
10903 New Hampshire Ave.
Silver Spring, MD 20993

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
Nancy Hayes (Acting)
(DKKNAA)

OFFICE OF EXECUTIVE PROGRAMS
Director
Mary Beth Clarke
(DKKNH)

OFFICE OF MANAGEMENT
Director
Melanie Keller, M.B.A.
(DKKNB)

OFFICE OF COMMUNICATIONS          
Director
Julie A. Zawisza, M.A.
(DKKNC)

OFFICE OF COUNTER-TERRORISM AND EMERGENCY COORDINATION
Director
Rosemary Roberts, M.D.
(DKKNL)

OFFICE OF COMPLIANCE
Director
Howard Sklamberg, J.D.
(DKKND)

Reports directly to the Office Director: 

OFFICE OF MANUFACTURING AND PRODUCT QUALITY
Director
Steven Lynn
(DKKNDA)

OFFICE OF UNAPPROVED DRUGS AND LABELING COMPLIANCE
Director
Thomas Cosgrove
(DKKNDD)

OFFICE OF SECURITY, INTEGRITY, AND RECALLS
Director
Thomas J. Christl
(DKKNDF)

OFFICE OF SCIENCE INVESTIGATIONS
Director
Thomas Moreno (Acting)
(DKKNDE)

Reports directly to the Center Director:

OFFICE OF MEDICAL POLICY
Director
Rachel E. Sherman, M.D., M.Ph.
(DKKNF)

Reports directly to the Office Director: 

OFFICE OF PRESCRIPTION DRUG PROMOTION
Director
Thomas W. Abrams
(DKKNFA)

OFFICE OF MEDICAL POLICY INITIATIVES
Director
CMDR Richardae Araojo (Acting)
(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)

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 DRUG EVALUATION IV
Director
Charles J. Ganley, M.D.
(DKKNRE)

OFFICE OF ANTIMICROBIAL PRODUCTS
Director
Edward M. Cox, M.D., M.Ph.
(DKKNRD)

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 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
Gary Slatko, M.D.
(DKKNOG)

OFFICE OF PHARMACOVIGILANCE AND EPIDEMIOLOGY
Director
Solomon Iyasu, M.D., M.Ph.
(DKKNOH)

Reports directly to the Center Director:

OFFICE OF PHARMACEUTICAL SCIENCE
Director
Lawrence Yu (Acting)
(DKKNS)

Reports directly to the Office Director:

OFFICE OF GENERIC DRUGS
Director
Kathleen Uhl, M.D. (Acting)
(DKKNSB)

OFFICE OF NEW DRUG QUALITY ASSESSMENT
Director
Christine Moore, Ph.D. (Acting)
(DKKNSC)

OFFICE OF TESTING AND RESEARCH
Director
Lucinda Buhse, Ph.D. (Acting)
(DKKNSD)

OFFICE OF BIOTECHNOLOGY PRODUCTS
Director
Steven Kozlowski, M.D.
(DKKNSE)

Approved by the FDA Reorganization Coordinator and Principal Delegations Control Officer