US Departments and Offices

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office for Human Research Protection

Director

Jerry Menikoff (240) 453-6900

Deputy Director and Director, Office of International Activities

Melody Lin (240) 453-8126

Associate Director, Regulatory Affairs

Michael Carome (240) 453-8237

Senior Advisor to the Director

Ivor Pritchard (240) 453-8230

Director, Division of Compliance Oversight

Kristina Borror (240) 453-8132

Director, Division of Education and Development

Elyse Summers* (240) 453-8236

Director, Division of Policy and Assurances

Irene Stith-Coleman (240) 453-8138

FOOD AND DRUG ADMINISTRATION

Office of the FDA Commissioner

Commissioner

Margaret Hamburg (301) 796-5000

Principal Deputy Commissioner

Joshua Sharfstein (301) 796-5040

Chief Counsel

Ralph Tyler (301) 796-8535

Deputy Commissioner for Policy, Planning and Budget

David Dorsey (301) 796-4800

Deputy Commissioner for Science & Public Health & Chief Scientist

Jesse Goodman (301)796-4880

Assistant Commissioner for Counterterrorism & Emerging Threats

Boris Lushniak (301) 796-8512

Director, Office of Critical Path Programs

Leonard Sacks* (301) 796-8490

Deputy Commissioner for International Programs

Murray Lumpkin (301) 796-8400

Associate Commissioner for International Programs

Mary Lou Valdez (301) 796-8400

Associate Commissioner for External Affairs

Beth Martino (301) 796-7603

Assistant Commissioner for External Relations

Larry Bachorik (301) 796-8643

Assistant Commissioner for Public Affairs

George Strait (301)796-4540

Director, Office of Special Health Issues

Theresa Toigo (301) 796-8460

Associate Commissioner for Special Medical Programs

Jill Warner* (301) 796-4810

Director, Office of Pediatric Therapeutics

Dianne Murphy (301) 796-8651

Director, Office of Combination Products

Thinh Nguyen (301) 796-8931

Director, Office of Orphan Products Development

Timothy Cote (301) 796-8662

Director, Office of Good Clinical Practice

Joanne Less (301) 796-8340

Senior Bioethicist

Sara Goldkind (301) 796-8340

Senior Advisor for Clinical Science

David Lepay (858) 550-3850

Senior Health Policy Analyst

Kathleen Pfaender (301) 796-8340

Senior Health Policy Analyst

Doreen Kezer (301) 796-8340

Policy Analyst

Marsha Melvin (301) 796-8340

Policy Analyst

Bridget Folz (301) 796-8340

Biophysicist

Jean Toth-Allen (301) 796-8340

Director, Office for Women's Health

Marsha Henderson (301) 796-9439

Director, National Center for Toxicological Research

William Slikker (870) 543-7203

Director, Center for Tobacco Products

Lawrence Deyton (877) 287-1373

Office of Regulatory Affairs

Associate Commissioner for Regulatory Affairs

Dara Corrigan (301) 796-8800

Assistant Commissioner for Field Operations

Michael Chappell (301) 827-3107

Assistant Commissioner for Compliance Policy

Steven Solomon (301) 827-3101

Center for Devices and Radiological Health

Director

Jeffrey Shuren (301) 796-5900

Deputy Director & Chief Scientist

William Maisel (301) 796-5900

Senior Associate Director

Lillian Gill (240) 796-5900

Director, Office of Device Evaluation

Christy Foreman* (301) 796-5550

Director, Office of Compliance

Steven Silverman (301) 796-5500

Director, Division of Bioresearch Monitoring

Michael Marcarelli (301) 796-5490

Director, Office of In Vitro Diagnostic Device Evaluation and Safety

Alberto Gutierrez (301) 796-5453

Director, Office of Surveillance and Biometrics

Susan Gardner (240) 796-5996

Center for Drug Evaluation and Research (CDER)

Director

Janet Woodcock (301) 796-5400

Deputy Director for Regulatory Programs

Douglas Throckmorton (301) 796-5400

Deputy Director for Clinical Science

Robert Temple (301) 796-2270

Associate Director for International Programs

Justina Molzon (301) 796-5400

Associate Director for Regulatory Policy

Jane Axelrad (301) 796-5400

Associate Director for Planning and Business Informatics

Theresa Mullin (301) 796-3422

Director, Office of Executive Programs

Deborah Henderson (301) 796-1446

Director, Office of Management

Marg Milline (301) 796-3300

Director, Office of Communication

Julie Zawisza (301) 796-3700

Director, Office of Counterterrorism and Emergency Coordination

Rosemary Roberts (301) 796-2210

Office of Translational Services

Director

ShaAvhree Buckman (301) 796-1721

Director, Office of Clinical Pharmacology

Lawrence Lesko (301) 796-1565

Director, Office of Biostatistics

Robert O'Neill (301) 796-1700

Office of Compliance

Director

Deborah Autor (301) 796-3100

Deputy Director

Ilisa Bernstein* (301) 796-3100

Director, Division of Scientific Investigations

Leslie Ball (301) 796-3150

Deputy Director

Joseph Salewski (301) 796-3395

Chief, Good Clinical Practices Branch I

Constance Lewin (301) 796-3397

Chief, Good Clinical Practices Branch II

Tejashri Purohit-Sheth (301) 796-3402

Chief, GLP/Bioequivalence Branch

Sam Haidosh (301) 796-4477

Office of Medical Policy

Director

Rachel Behrman (301) 796-2500

Director, Division of Drug Marketing, Advertising, and Communications

Thomas Abrams (301) 796-1200

Director, Office of Planning & Informatics

Theresa Mullins (301) 796-3422

Office of New Drugs

Director

John Jenkins (301) 796-0700

Deputy Director

Sandra Kweder (301) 796-0700

Director, Office of Drug Evaluation I

Robert Temple* (301) 796-2270

Director, Office of Drug Evaluation II

Curtis Rosebraugh (301) 796-2310

Director, Office of Drug Evaluation III

Julie Beitz (301) 796-2100

Director, Office of Antimicrobial Products

Edward M. Cox (301) 796-1300

Director, Office of Oncology Products

Richard Pazdur (301) 796-2340

Director, Office of Nonprescription Products

Charles Ganley (301) 796-0895

Office of Pharmaceutical Science

Director

Helen Winkle (301) 796-2400

Director, Science & Research Staff

Nakissa Sadrieh (301) 796-1598

Director, Office of New Drug Quality Assessment

Moheb Nasr (301) 796-1724

Director, Office of Generic Drugs

Keith Webber* (240) 276-9310

Director, Office of Testing and Research

Vincent Vilker (301) 796-0200

Director, Office of Biotechnology Products

Steven Kozlowski (301) 796-2390

Office of Surveillance and Epidemiology

Director

Gerald DalPan (301) 796-2380

Deputy Director

Henry "Skip" Francis (301) 796-2380

Director, Division of Risk Management

Mary Willy (301) 796-5400

Director, Division of Epidemiology

Solomon Iyasu (301) 796-2370

Director, Division of Medication Error Prevention and Analysis

Carol Holquist (301) 796-2360

Director, Division of Pharmacovigilance I

Mark Avigan (301) 796-2350

Director, Division of Pharmacovigilance II

Robert Boucher (301) 796-2350

Center for Biologics Evaluation and Research (CBER)

Director

Karen Midthun (301) 827-0372

Senior Scientist for Emerging & Pandemic Threat Preparedness

David Cho (301) 827-6352

Associate Director for Research

Carolyn Wilson (301) 827-0481

Associate Director for Policy

Diane Maloney (301) 827-0372

Associate Director for Quality Assurance

Sheryl Lard-Whiteford (301) 827-0379

Associate Director for Review Management

Robert Yetter (301) 827-0373

Science Communications Advisor

Marc Kusinitz (301) 827-0372

Senior Advisor for International Affairs

Joan W. Blair (301) 827-0639

Senior Advisory for Counterterrorism/Medical Countermeasures:

Cynthia Kelley (3010 827-0636

Senior Advisor for Chemistry and Manufacturing Controls

Christopher Joneckis (301) 435-5681

Director, Office of Biostatistics and Epidemiology

Robert Ball (301) 827-3034

Director, Office of Information Technology

Ginger Leo (301) 827-1368

Director, Office of Communication,Outreach & Development

Lorrie McNeill (301) 827-2000

Director, Office of Management

James Sigg (301) 827-1320

Director, Office of Information Technology

Ginger Leo (301) 827-1368

Director, Office of Blood Research & Review

Jay Epstein (301) 827-3518

Director, Office of Vaccines Research & Review

Norman Baylor (301) 827-5105

Director, Office of Cellular, Tissue, and Gene Therapies

Celia Witten (301) 827-5102

Director, Office of Compliance & Biologics Quality

Mary Anne Malarkey (301) 827-6190

Director, Division of Inspections & Surveillance

Gilliam Conley (301) 827-6220

Director, Bioresearch Monitoring Branch

Patricia Holobaugh (301) 827-6220

NIH Institutes, Center, and Divisions

*Acting

**E-mail for FDA staff:firstname.lastname@fda.hhs.gov