Patrizia Cavazzoni, M.D.
Director for Center for Drug Evaluation and Research
Patrizia Cavazzoni, M.D., is the director of the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration. The Center ensures that safe and effective drugs are available to improve the health of the people in the United States.
Jacqueline Corrigan-Curay, J.D., M.D.
Principal Deputy Center Director
Jacqueline Corrigan-Curay, J.D., M.D., is the Principal Deputy Center Director in FDA’s Center for Drug Evaluation and Research (CDER). Most recently, she served as the Acting Center Deputy Director for Operations, directing center and agency-level priority and initiative programs and leading GDUFA III reauthorization negotiations.
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.
Marta Sokolowska, Ph.D.
Deputy Center Director for Substance Use and Behavioral Health
Marta Sokolowska, Ph.D., is the Deputy Center Director for Substance Use and Behavioral Health in FDA’s Center for Drug Evaluation and Research (CDER).
Robert Temple, M.D.
Senior Advisor for Clinical Science
Dr. Robert Temple serves as Senior Advisor for Clinical Science in CDER’s Office of the Center Director and Senior Advisor in the Immediate Office of the Office of New Drugs.
Elizabeth Jungman, J.D., M.P.H.
Associate Director for Policy
Director, Office of Regulatory Policy
Elizabeth Jungman, J.D., M.P.H., serves as CDER’s Associate Director for Policy and Director of the Office of Regulatory Policy (ORP). Ms. Jungman serves as the Center’s primary representative for broad policy matters and issues related to human drugs. She advises the Center Director and FDA officials on all matters involving drug policy development, execution, and long-range program goals.
Theresa M. Mullin, Ph.D.
Associate Director for Strategic Initiatives
Theresa Mullin, Ph.D., serves as CDER’s Associate Director for Strategic Initiatives. She oversees areas of strategic interest to external stakeholders. She leads the Patient-Focused Drug Development (PFDD) initiative, which includes work related to the FDA Reauthorization Act (FDARA) and implementation of the 21st Century Cures Act. She also leads CDER’s International Program.
LCDR Amy Ramanadham, Pharm.D., M.S.
Acting Associate Director for Drug Safety Operations
LCDR Amy Ramanadham, Pharm.D., M.S., serves as CDER’s Acting 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 complex safety issues.
ShaAvhree 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 CDER’s executive operations, legislative affairs, and project management; learning and organizational development; scientific advisory committee program; product jurisdiction and combination products; and formal dispute resolution and ombudsman services.
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.
M. Khair ElZarrad, Ph.D., M.P.H.
Director - Office of Medical Policy
M. Khair ElZarrad, Ph.D., M.P.H., is the Director of the Office of Medical Policy (OMP) in FDA’s Center for Drug Evaluation and Research (CDER). He has served as the Deputy Director of OMP since 2017.
Peter Stein, M.D.
Director, Office of New Drugs
Peter Stein, M.D., is the Director of CDER’s Office of New Drugs (OND). OND is responsible for the regulatory oversight of investigational studies during drug development and decisions regarding marketing approval for new (innovator or non-generic) drugs, including decisions related to changes to already marketed products. OND provides guidance to regulated industry on a wide variety of clinical, scientific, and regulatory matters.
Eric Stone, M.B.A.
Director, Office of Management
Eric Stone is Director of CDER's Office of Management. He also serves as the CDER Executive Officer and CDER’s Associate Director for Management. He leads the center’s administrative management operations, which includes more than 5,000 employees and an annual budget of more than $1 billion, comprised of a mix of congressional appropriations and multiple user fee programs. Under Mr. Stone’s leadership, the Office of Management staff manages all aspects of: ethics management, human capital management, financial management (including budget formulation, user-fee collection, and budget execution), acquisition management, employee safety, and facilities management.
Mary Ann Slack
Director, Office of Strategic Programs
Mary Ann Slack serves as Director of CDER’s Office of Strategic Programs (OSP). OSP plays a lead role in many of the center’s strategic initiatives and modernization efforts, including development of benefit-risk and other decision support tools, data standardization, lean process management, program analysis, informatics, capacity planning, and major user fee negotiations. OSP leads implementation of CDER’s business informatics governance function in support of business modernization objectives.
Jill Furman, J.D.
Director, Office of Compliance
Jill Furman, J.D., serves as the Director of the Office of Compliance in the Center for Drug Evaluation and Research (CDER). The Office of Compliance is charged with protecting the public from poor quality, unsafe, and ineffective drug products through proactive compliance strategies and risk-based enforcement actions.
James-Denton (JD) Wyllie
Director, Office of Communications
James-Denton (JD) Wyllie serves as the Executive Director of CDER’s Office of Communications (OCOMM), where he manages CDER’s public outreach and internal communications programs. His expertise includes public affairs program management, strategic communications planning, organizational marketing, digital communication operations, stakeholder outreach, media relations and crisis communications.
Iilun Murphy, M.D.
Director, Office of Generic Drugs
Iilun Murphy, M.D., serves as the Director of the Office of Generic Drugs (OGD) in the Center for Drug Evaluation and Research (CDER). This office is responsible for the review and approval of abbreviated new drug applications.
Michael Kopcha, Ph.D., R.Ph.
Director, Office of Pharmaceutical Quality
Michael (Mike) Kopcha, 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.