Janet Woodcock, M.D.
Director, Center for Drug Evaluation & Research
Janet Woodcock is Director of the Center for Drug Evaluation and Research (CDER), at the Food and Drug Administration (FDA). As of January 2015, Dr. Woodcock also assumed the role of Acting Director of CDER’s newly formed Office of Pharmaceutical Quality, (OPQ).
Douglas Throckmorton, M.D.
Deputy Center Director for Regulatory Programs
As Deputy Director for Regulatory Programs, Dr. Throckmorton shares the responsibility for overseeing the regulation of research, development, manufacture and marketing of prescription, over-the-counter, and generic drugs in the United States. He is committed to ensuring that the benefits of approved drugs outweigh their known risks.
Robert Temple, M.D.
Deputy Center Director for Clinical Science
Robert Temple serves as CDER's Deputy Center Director for Clinical Science and also Acting Deputy Director of the Office of Drug Evaluation I (ODE-I). He has served in this capacity since the office's establishment in 1995.
Richard A. Moscicki, M.D.
Deputy Center Director for Science Operations
Richard (Rich) A. Moscicki (Mo-shis-ke), M.D., joined the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), as Deputy Center Director for Science Operations in April of 2013. In this position, Dr. Moscicki is responsible for executive direction of Center operations and leadership in overseeing the development, implementation, and direction of CDER’s programs.
Jane Axelrad, JD
Associate Director for Policy, CDER
Jane Axelrad, the Associate Director for Policy, CDER, serves as the Agency lead on managing policy, surveillance and enforcement, legislative, and oversight issues related to pharmacy compounding arising out of the meningitis outbreak. She also manages other high-priority projects that cut across office lines.
Theresa A. Toigo, MBA, RPh
Associate Director for Drug Safety Operations
Theresa (Terry) Toigo serves as CDER’s Associate Director for Drug Safety Operations. She is responsible for the management of significant and timely drug safety issues, as well as the creation and oversight of CDER processes for management of cross-office and cross-Center safety issues.
ShaAvhrée Buckman-Garner, M.D., Ph.D., FAAP
Director, Office of Translational Sciences
ShaAvhrée Buckman-Garner, M.D., Ph.D., FAAP is the Director of CDER's Office of Translational Sciences (OTS). OTS is comprised of the Office of Biostatistics, Office of Clinical Pharmacology, Office of Computational Science, Office of Study Integrity and Surveillance, provides oversight to CDER research involving human subjects, the CDER ORISE Program, as well as CDER regulatory science research. OTS is responsible for providing coordination for Critical Path initiatives across CDER in partnership with individual CDER offices.
Mary Beth Clarke
Director, Office of Executive Programs
As Director of the Office of Executive Programs, Mary Beth Clarke oversees a variety of Center-wide programs, including an executive project management staff, the Center’s executive secretariat function, the scientific advisory committee program, the Division of Training & Development, the office of the CDER ombudsman.
Gerald Dal Pan, M.D., M.H.S.
Director, Office of Surveillance and Epidemiology
Gerald J. Dal Pan became the Director of the Office of Surveillance and Epidemiology (known then as the Office of Drug Safety) in November 2005. Before that, he was the Director of the Division of Surveillance, Research, and Communication Support.
Grail Sipes, JD
Director, Office of Regulatory Policy
Grail Sipes is the Director of CDER’s Office of Regulatory Policy (ORP), which is responsible for managing the development of new regulations and policies applicable to FDA’s regulation of human pharmaceuticals, including preparing responses to citizen petitions.
John Jenkins, M.D.
Director, Office of New Drugs
John Jenkins joined FDA as a medical officer in the Division of Oncology and Pulmonary Drug Products in 1992. He subsequently served as Pulmonary Medical Group Leader and Acting Division Director before being appointed as Director of the newly created Division of Pulmonary Drug Products in 1995.
Melanie Keller, MBA
Director, Office of Management
Melanie Keller serves as the CDER Executive Officer and Director of CDER's Office of Management. She leads the Center’s administrative management operations, which includes nearly 5,000 employees and an annual budget over $1 billion comprised of a mix of congressional appropriations and multiple user fee programs.
Theresa M. Mullin, Ph.D.
Director, Office of Strategic Programs
Theresa M. Mullin directs strategic programs including business informatics for CDER. The Office of Strategic Programs plays a lead role in a number of CDER’s strategic initiatives and modernization efforts including development of benefit-risk and other decision support tools, the international program, data standardization, lean management, program analysis, informatics, and major user fee negotiations.
CAPT Denise Hinton
Acting Director, Office of Medical Policy
CAPT Denise Hinton serves as Acting Director of CDER’s Office of Medical Policy (OMP). She leads the development, coordination, and implementation of medical policy programs and strategic initiatives.
Cynthia Schnedar, JD
Director, Office of Compliance
As Director of CDER’s Office of Compliance, Cynthia Schnedar, J.D., leads efforts to protect the American public from unsafe and ineffective drug products by ensuring that companies comply with federal standards for quality and safety.
Director, Office of Communications
Christine Shreeve is Director of CDER’s Office of Communications (OCOMM). She oversees CDER’s public outreach and internal communications programs. Ms. Shreeve’s expertise includes communications strategy, strategic planning and evaluation, coalition building, policy analysis, communications program managements, writing, and media relations.
Kathleen Uhl, M.D.
Director, Office of Generic Drugs
Kathleen (Cook) Uhl, M.D. serves as the Director for the Office of Generic Drugs in the Center for Drug Evaluation and Research. This office is responsible for the review and approval of Abbreviated New Drug Applications (ANDAs).
Michael Kopcha, Ph.D.
Director, Office of Pharmaceutical Quality
Michael (Mike) Kopcha (“cop-cha”), Ph.D., R.Ph., serves as Director of the Office of Pharmaceutical Quality (OPQ) in the Center for Drug Evaluation and Research. OPQ combines non-enforcement-related drug quality work into one super-office.
Rosemary Roberts, M.D.
Director, Counter-Terrorism and Emergency Coordination Staff
Dr. Rosemary Roberts is the Director for the newly realigned Staff, renamed Counter-Terrorism and Emergency Coordination Staff (CTECS) in the Office of the Center Director, as of September 2014. Prior to the realignment, Dr. Roberts was the Director of the Office of Counter-Terrorism and Emergency Coordination (OCTEC) from September 2004 to September 2014. CTECS works with sponsors developing countermeasures against chemical, biological, radiological and nuclear (CBRN) threats prior to the pre-IND stage. In addition, CTECS is the FDA point of contact for the Strategic National Stockpile (SNS) which is maintained by the CDC. CTECS is also responsible for coordinating emergency preparedness and response for CDER.