CDER Leadership Bios
Janet Woodcock, M.D.
Director, Center for Drug Evaluation & Research
Janet Woodcock has held various leadership positions within FDA’s Office of the Commissioner, including Deputy Commissioner and Chief Medical Officer, Deputy Commissioner for Operations and Chief Operating Officer, and Director of Critical Path Programs.
Douglas Throckmorton, M.D.
Deputy Center Director for Regulatory Programs
As the Deputy Center Director for Regulatory Programs in CDER, Douglas Throckmorton shares responsibility for overseeing the regulation of research, development, manufacture and marketing of prescription, over-the-counter, and generic drugs in the United States.
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 A. Moscicki serves as CDER’s Deputy Center Director for Science Operations. He shares in the executive direction of Center operations and provides leadership in overseeing the development, implementation, and direction of our 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 is the Director of CDER's Office of Translational Sciences (OTS). OTS is comprised of the Office of Biostatistics, Office of Clinical Pharmacology, and provides oversight to CDER research involving human subjects as well as CDER regulatory science research.
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.
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 joined CDER in December 2010 as Executive Officer and Director of CDER's Office of Management. Before that, she served as the Executive Officer at the Center for Science Review (CSR) at the National Institutes of Health (NIH).
Theresa M. Mullin, Ph.D.
Director, Office of Strategic Programs
Theresa Mullin directs strategic planning and business informatics for CDER. The Office of Strategic Programs plays a lead role in CDER’s long-range planning, budget formulation, program analysis, and informatics operations.
Denise Hinton, CAPT
Acting Director, Office of Medical Policy
As Acting Director of CDER’s Office of Medical Policy, Denise Hinton is responsible for developing, coordinating, and implementing 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.
Kathleen Uhl, M.D.
Acting Director, Office of Generic Drugs
Kathleen (Cook) Uhl, M.D. serves as the Acting 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).
Lawrence Yu, Ph.D.
Acting Director, Office of Pharmaceutical Science
As Acting Director of the Office of Pharmaceutical Science (OPS), Lawrence Yu, directs the activities of the office’s quality review programs and its laboratory activities for small molecules and proteins.
Rosemary Roberts, M.D.
Director, Office of Counter-Terrorism and Emergency Coordination
Rosemary Roberts has been the Director of the Office of Counter-Terrorism and Emergency Coordination since September 2004. OCTEC works with sponsors developing countermeasures against chemical, biological, radiological and nuclear threats.