Janet Woodcock, M.D.
Director (on detail to Operation Warp Speed) for Center for Drug Evaluation and Research
Janet Woodcock is Director of the Center for Drug Evaluation and Research (on detail to Operation Warp Speed), at the Food and Drug Administration. As of January 2015, Dr. Woodcock also assumed the role of Acting Director of CDER’s newly formed Office of Pharmaceutical Quality, (OPQ).
Patrizia Cavazzoni, M.D.
Acting Director for Center for Drug Evaluation and Research
Deputy Center Director for Operations
Patrizia Cavazzoni, M.D., is the acting 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..
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
Dr. Robert Temple serves as CDER’s Deputy Center Director for Clinical Science and Senior Advisor in the Immediate Office of the Office of New Drugs (OND). As the senior advisor, Bob is a consultant to the OND director and other FDA officials on matters related to clinical program objectives.
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.
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.
Theresa A. Toigo MBA, 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.
Marta Sokolowska, Ph.D.
Associate Director for Controlled Substances
Marta Sokolowska, Ph.D., serves as Associate Director for Controlled Substances in the Center for Drug Evaluation and Research. She joined FDA in December 2018 and oversees the Controlled Substances Program (CSP).
ShaAvhree Buckman-Garner MD, 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.
Elizabeth Jungman, J.D., M.P.H.
Director, Office of Regulatory Policy
As Director of CDER’s Office of Regulatory Policy (ORP), Elizabeth Jungman, J.D., M.P.H., 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).
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.
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.
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.
James-Denton (JD) Wyllie
Director, Office of Communications
James-Denton (JD) Wyllie is Director of CDER’s Office of Communications (OCOMM). He oversees CDER’s public outreach and internal communications programs. His expertise includes public affairs program management, strategic communications planning, organizational marketing, digital communication operations, community communications outreach, writing and editing, media relations and crisis communications.
Sally Choe, Ph.D.
Director, Office of Generic Drugs
Sally Choe, Ph.D., serves as Director of the Office of Generic Drugs (OGD) 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., 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.
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.