About FDA

CDER Leadership Bios

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Janet Woodcock
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).

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Douglas Throckmorton
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. 

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Robert Temple
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.  

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Patrizia Cavazzoni, M.D.
Patrizia Cavazzoni, M.D.
Deputy Center Director for Operations

Patrizia Cavazzoni, M.D., is the Deputy Director for Operations at FDA’s Center for Drug Evaluation and Research (CDER). In this position, Dr. Cavazzoni provides strategic leadership related to regulatory and scientific programs.

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Grail Sipes
Grail Sipes, J.D.
Deputy Center Director for Regulatory Policy

Grail Sipes is the Deputy Center Director for Regulatory Policy at FDA’s Center for Drug Evaluation and Research (CDER). In this position, Ms. Sipes is responsible for broad policy matters and issues in all areas related to human drugs.

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Theresa Mullin
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.

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Theresa Toigo
Theresa A. Toigo, M.B.A., R.Ph.
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.

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Julie Dohm
Julie Dohm, J.D., Ph.D.
Senior Science Advisor for Compounding

Julie Dohm serves as the Agency lead on compounding. She is responsible for the overall leadership of FDA’s compounding initiative. She leads compounding activities of multiple offices throughout the Agency, developing and managing teams to implement legislation, perform inspections, prepare enforcement actions, develop policy, and conduct outreach to stakeholders.

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ShaAvhree Buckman
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.

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Mary Beth Clarke
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.

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Gerald Dal Pan
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.

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Carol Bennett, J.D
Carol Bennett, J.D.
Acting Director, Office of Regulatory Policy

As Acting Director of CDER’s Office of Regulatory Policy (ORP), Carol Bennett, J.D., helps oversee the development and implementation of regulations, policies, and procedures that affect nearly every aspect of the Center for Drug Evaluation and Research (CDER).

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Female Silhouette
Janet Woodcock, M.D.
Acting Director, Office of New Drugs

Janet Woodcock is Director of the Center for Drug Evaluation and Research (CDER) and Acting Director of the Office of New Drugs at the Food and Drug Administration (FDA). In 2015, Dr. Woodcock also operated in the role of Acting Director of CDER’s Office of Pharmaceutical Quality (OPQ).

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Gary Mays
Gary Mays, M.B.A., PMP
Acting Director, Office of Management

Gary Mays serves as the CDER Executive Officer and Acting Director of CDER's Office of 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.

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Mary Ann Slack
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. 

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Jacqueline Corrigan-Curay, J.D., M.D.
Jacqueline Corrigan-Curay, J.D., M.D.
Director, Office of Medical Policy

Jacqueline Corrigan-Curay, J.D., M.D., serves as Director of CDER’s Office of Medical Policy (OMP). She leads the development, coordination, and implementation of medical policy programs and strategic initiatives. She works collaboratively with other CDER program areas, FDA centers, and stakeholders on enhancing policies to improve drug development and regulatory review processes.

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Donald D. Ashley, J.D.
Donald D. Ashley, J.D.
Director, Office of Compliance

As Director of CDER’s Office of Compliance (OC), Donald D. Ashley, 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.

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Christine Shreeve
Christine Shreeve
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.

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Kathleen Uhl

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).
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Michael Kopcha
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.

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Rosemary Roberts 
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.

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