CDER Organization Chart

The following header reflects the organizational hierarchy.

DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
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 telephone: 301-796-5400
Fax: 301-847-8752
Address:
White Oak Bldg. 51, Rm. 6130
10903 New Hampshire Ave.
Silver Spring, MD 20993

The following is the Food and Drug Administration’s, 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.

OFFICE OF THE CENTER DIRECTOR
DIRECTOR
Janet Woodcock, M.D.
(DBNA)

OFFICE OF REGULATORY POLICY
DIRECTOR
Jane A. Axelrad
(DBNAA)

OFFICE OF MANAGEMENT
DIRECTOR
Russell J. Abbott
(DBNB)

OFFICE OF TRAINING AND COMMUNICATIONS
DIRECTOR
Julie A. Zawisza
(DBNC)

OFFICE OF COMPLIANCE
DIRECTOR
Deborah M. Autor, Esq.
(DBND)

OFFICE OF INFORMATION TECHNOLOGY
DIRECTOR
James Shugars
(DBNE)

OFFICE OF MEDICAL POLICY
DIRECTOR
Robert J. Temple, M.D.
(DBNF)

OFFICE OF EXECUTIVE PROGRAMS
DIRECTOR
Deborah J. Henderson
(DBNH)

OFFICE OF TRANSLATIONAL SCIENCES
DIRECTOR
ShaAvhree Buckman, M.D., Ph.D. (Acting)
(DBNG)

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

OFFICE OF NEW DRUGS
DIRECTOR
John K. Jenkins, M.D.
(DBNR)

OFFICE OF BUSINESS PROCESS SUPPORT
DIRECTOR
Mary Ann Slack
(DBNM)

OFFICE OF SURVEILLANCE AND EPIDEMIOLOGY
DIRECTOR
Gerald J. Dal Pan, M.D., M.H.S.
(DBNO)

OFFICE OF PHARMACEUTICAL SCIENCE
DIRECTOR
Helen N. Winkle
(DBNS)

Reporting to the DIRECTOR, OFFICE OF TRANSLATIONAL SCIENCES are the following:

OFFICE OF BIOSTATISTICS
DIRECTOR
Robert T. O'Neill, Ph.D.
(DBNGB)

OFFICE OF CLINICAL PHARMACOLOGY
DIRECTOR
Lawrence J. Lesko, Ph.D.
(DBNGC)

Reporting to the DIRECTOR, OFFICE OF NEW DRUGS are the following:

OFFICE OF DRUG EVALUATION I
DIRECTOR
Robert J. Temple, M.D. (Acting)
(DBNRA)

OFFICE OF DRUG EVALUATION II
DIRECTOR
Curtis Rosebraugh, M.D.
(DBNRB)

OFFICE OF DRUG EVALUATION III
DIRECTOR
Julie G. Beitz, M.D.
(DBNRC)

OFFICE OF ANTIMICROBIAL PRODUCTS
DIRECTOR
Edward M. Cox, M.D., M.P.H.
(DBNRD)

OFFICE OF NONPRESCRIPTION PRODUCTS
DIRECTOR
Charles J. Ganley, M.D.
(DBNRE)

OFFICE OF ONCOLOGY DRUG PRODUCTS
DIRECTOR
Richard Pazdur, M.D.
(DBNRK)

Reporting to the DIRECTOR, OFFICE OF PHARMACEUTICAL SCIENCE are the following:

OFFICE OF GENERIC DRUGS
DIRECTOR
Gary J. Buehler
(DBNSB)

OFFICE OF NEW DRUG QUALITY ASSESSMENT
DIRECTOR
Moheb M. Nasr, Ph.D.
(DBNSC)

OFFICE OF TESTING AND RESEARCH
DIRECTOR
Vincent Vilker Ph.D.
(DBNSD)

OFFICE OF BIOTECHNOLOGY PRODUCTS
DIRECTOR
Steven Kozlowski, M.D.
(DBNSE)

Prepared by the Office of Management Programs, OM - 10/22/08

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