CDER - Organization - Text version

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. 6133

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, J.D.

(DBNAA)

 

OFFICE OF

MANAGEMENT

DIRECTOR

Robert Linkous (Acting)

(DBNB)

 

OFFICE OF

TRAINING AND COMMUNICATIONS          

DIRECTOR

Julie A. Zawisza

(DBNC)

 

OFFICE OF

COMPLIANCE

DIRECTOR

Deborah M. Autor, Esq. LLB.,J.D.

(DBND)

 

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)

 

The following offices reports to the DIRECTOR, OFFICE OF NEW DRUGS:

 

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.

(DBNRM)

 

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

 

OFFICE OF

GENERIC DRUGS

DIRECTOR

Gary J. Buehler, J.D.

(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)

 

Approved by the Office of Management Programs, OM - 09/04/09