U.S. flag An official website of the United States government
  1. Home
  2. About FDA
  3. FDA Organization
  4. Office of Medical Products and Tobacco
  5. Center for Drug Evaluation and Research | CDER
  6. CDER Leadership Bios
  1. Center for Drug Evaluation and Research | CDER

CDER Leadership Bios

Janet Woodcock, M.D.
Janet Woodcock, M.D.

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).

More about Janet Woodcock, M.D.


Douglas Throckmorton, M.D.
Douglas Throckmorton, M.D.

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.

More about Douglas Throckmorton, M.D.


Robert Temple, M.D.
Robert Temple, M.D.

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.

More about Robert Temple, M.D.


Patrizia Cavazzoni, M.D.
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.

More about Patrizia Cavazzoni, M.D.


Gail Sipes, J.D.
Grail Sipes, J.D.

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.

More about Grail Sipes J.D.


Theresa M. Mullin, Ph.D.
Theresa M. Mullin, Ph.D.

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.

More about Theresa M. Mullin Ph.D.


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

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.

More about Theresa A. Toigo MBA, R.Ph


Marta Sokolowska, Ph.D.
Marta Sokolowska, Ph.D.

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 Substance Staff (CSS).

More about Marta Sokolowska Ph.D.


ShaAvhrée Buckman-Garner, M.D., Ph.D., FAAP
ShaAvhrée Buckman-Garner, M.D., Ph.D., FAAP

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.

More about ShaAvhree Buckman-Garner MD, Ph.D., FAAP


Mary Beth Clarke
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.

More about Mary Beth Clarke


Gerald Dal Pan, M.D., M.H.S.
Gerald Dal Pan, M.D., M.H.S.

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.

More about Gerald J. Pan, M.D., M.H.S.


Elizabeth Jungman, J.D., M.P.H.
Elizabeth Jungman, J.D., M.P.H.

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).

More about Elizabeth Jungman, J.D., M.P.H.


Peter Stein, M.D.
Peter Stein, M.D.

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.

More about Peter Stein, M.D.


Eric Stone, M.B.A.
Eric Stone, M.B.A.

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.

More about Eric Stone, M.B.A.


Mary Ann Slack
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.

More about Mary Ann Slack


Jacqueline Corrigan-Curay, J.D., M.D.
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.

More about Jacqueline Corrigan-Curay, J.D., M.D.


Donald D. Ashley, J.D.
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.

More about Donald D. Ashley, J.D.


Christine Shreeve
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.

More about Christine Shreeve


Sally Choe, Ph.D.
Sally Choe, Ph.D.

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).

More about Sally Choe, Ph.D.


Michael Kopcha, Ph.D., R.Ph.
Michael Kopcha, Ph.D., R.Ph.

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.

More about Michael Kopcha, Ph.D., R.Ph.


Rosemary Roberts, M.D.
Rosemary Roberts, M.D.

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.

More about Rosemary Roberts, M.D.