About FDA
CBER - Office of Compliance and Biologics Quality - Organization - Text version
The following header reflects the organizational hierarchy.
FOOD AND DRUG ADMINISTRATION
OFFICE OF MEDICAL PRODUCTS AND TOBACCO
CENTER FOR BIOLOGICS EVALUATION AND RESEARCH
OFFICE OF COMPLIANCE AND BIOLOGICS QUALITY
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: 301-827-6190
Fax: 301-827-3381
Address: RKW2 Bldg
The following is the Food and Drug Administration, Office of Medical Products and Tobacco, Center for Biologics Evaluation and Research, Office of Compliance and Biologics Quality 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
Mary Anne Malarkey
Reports directly to the Office Director
DEPUTY DIRECTOR
Mark Schwartz, J.D.
ASSOCIATE DIRECTOR FOR POLICY
Anita F. Richardson
ASSOCIATE DIRECTOR FOR REGULATORY POLICY
Diane Alexander
ASSOCIATE DIRECTOR FOR MANUFACTURING SCIENCE
Edward Patten, M.S.
ASSOCIATE DIRECTOR FOR SAFETY AND COMMUNICATION
Jean Makie
ASSOCIATE DIRECTOR FOR BIOINFORMATICS
Sujay Pandey, Ph.D.
(DKKBC)
Approved by the FDA Reorganization Coordinator and Principal Delegation Control Officer
