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                Center for Drug Evaluation and Research | CDER

Center for Drug Evaluation and Research | CDER

                        CDER Offices and Divisions
          Meeting Presentations | Drugs
          CDER Exclusivity Board


                        Accelerating Rare disease Cures (ARC) Program
          CDER Contact Information
          CDER Manual of Policies & Procedures | MAPP
          Frequently Asked Questions about CDER
          Reports & Budgets | CDER Home
          About FDA
          FDA Organization
          Center for Drug Evaluation and Research | CDER
          CDER Leadership BiosCenter for Drug Evaluation and Research | CDER CDER Leadership Bios
  
  	
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    PrintPatrizia Cavazzoni, M.D.
Patrizia Cavazzoni, M.D.


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.

More about Patrizia Cavazzoni, M.D.


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


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.

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


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


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).

More about Marta Sokolowska Ph.D.


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


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.

More about Robert Temple, M.D.


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


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.

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


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.


LCDR Amy Ramanadham, Pharm.D., M.S.
LCDR Amy Ramanadham, Pharm.D., M.S.


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.

More about LCDR Amy Ramanadham, Pharm. D., M.S.


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


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.

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 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.

More about Mary Beth Clarke


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


Gerald J. 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.


M. Khair ElZarrad Portrait
M. Khair ElZarrad, Ph.D., M.P.H.


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.

More about M. Khair ElZarrad, Ph.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.


Jose Galvez, M.D.
Jose Galvez, M.D.


Jose Galvez, M.D.*Acting Director, Office of Strategic Programs*

Jose Galvez, M.D., serves as Acting 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 Jose Galvez, M.D.


Jill Furman, J.D.
Jill Furman, J.D.


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.

More about Jill Furman, J.D.


James-Denton (JD) Wyllie
James-Denton (JD) Wyllie


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.

More about James-Denton (JD) Wyllie


Iilun Murphy, M.D.
Iilun Murphy, M.D.


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.

More about Iilun Murphy, M.D.


Michael Kopcha
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.

                                                                                  Content current as of:
      01/19/2024
              
              
Regulated Product(s)
		 DrugsCenter for Drug Evaluation and Research | CDER

          
                        CDER Offices and Divisions
          Meeting Presentations | Drugs
          CDER Exclusivity Board


                        Accelerating Rare disease Cures (ARC) Program
          CDER Contact Information
          CDER Manual of Policies & Procedures | MAPP
          Frequently Asked Questions about CDER
          Reports & Budgets | CDER
 
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