U.S. Departments and Offices

December 1, 2006

Applied Clinical Trials

Applied Clinical Trials, Applied Clinical Trials-12-01-2006, Volume 0, Issue 0

Washington editor Jill Wechsler provides an updated list of U.S. regulatory agency personnel.

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office for Human Research Protection

Director

Bernard Schwetz (240) 453-6900

NIH Institutes, Center, and Divisions

Deputy Director and Director, Office of International Activities

Melody Lin (240) 453-8126

Associate Director, Regulatory Affairs

Michael Carome (240) 453-8237

Director, Division of Compliance Oversight

Kristina Borror (240) 453-8132

Director, Division of Education and Development

Shirley Hicks (240) 453-8227

Director, Division of Policy and Assurances

Irene Stith-Coleman (240) 453-8138

FOOD AND DRUG ADMINISTRATION

Office of the FDA Commissioner

Commissioner

Andrew von Eschenbach* (301) 827-3310

Deputy Commissioner for Operations

Janet Woodcock (301) 827-3310

Deputy Commissioner for Policy

Scott Gottlieb (301) 827-9776

Deputy Commissioner for International and Special Programs

Murray Lumpkin (301) 827-5709

Chief Staff Officer and Associate Commissioner for Legislation

Patrick Ronan (301) 827-0087

Chief Counsel

Sheldon Bradshaw (301) 827-1137

Senior Associate Commissioner for Policy, Planning

Randall Lutter (301) 827-5292

Associate Commissioner for Science and Health Coordination

Norris Alderson (301) 827-3340

Assistant Commissioner for Science and Deputy Director, Office of Science & Health Coordination

Linda Tollefson (301) 827-3340

Associate Commissioner for External Relations

Jason Brodsky (301) 827-6251

Associate Commissioner for Planning

Theresa Mullin (301) 827-5292

Associate Commissioner for Management and Chief Financial Officer

Kathleen Heuer (301) 255-6762

Assistant Commissioner for Policy

Jeffrey Shuren (301) 827-3360

Assistant Commissioner for Counterterrorism Policy

Boris Lushniak (301) 827-4067

Assistant Commissioner for International Programs

Melinda Plaisier (301) 827-4480

Assistant Commissioner for Women's Health

Kathleen Uhl (301) 827-0350

Director, Office of Crisis Management

Ellen Morrison (301) 827-5660

Director, Office of Combination Products

Mark Kramer (301) 427-1934

Director, Office of Orphan Products Development

Marlene Haffner (301) 827-3666

Director, Office of Pediatric Therapeutics

Dianne Murphy (301) 827-9218

Director, Office of Special Health Issues

Theresa Toigo (301) 827-4460

Senior Advisor for Clinical Science

David Lepay (301) 827-3340

Special Assistant to the Director

Patricia Beers Block (301) 827-3340

Associate Director for Human Subject Protection Policy

Bonnie Lee (301) 827-3340

Expert Consumer Safety Officer

Carolyn Hommel (301) 827-3340

Biophysicist

Jean Toth-Allen (301) 827-3340

Office of Regulatory Affairs

Associate Commissioner for Regulatory Affairs

Margaret Glavin (301) 827-3101

Deputy Commissioner for Compliance Policy

David Horowitz (301) 827-3101

Deputy Commissioner for Field Operations

Diana Kolaitis (718) 662-5416

Senior Advisor for Clinical Science

Lori Love (301) 827-3684

Center for Devices and Radiological Health

Director

Daniel Schultz (240) 276-3139

Deputy Director

Linda Kahan (240) 276-3139

Director, Office of Device Evaluation

Donna Bea Tillman (240) 276-3993

Director, Office of Compliance

Timothy Ulatowski (301) 276-0100

Director, Division of Bioresearch Monitoring

Michael Marcarelli (301) 276-0125

Director, Office of In Vitro Diagnostic Device Evaluation and Safety

Steven Gutman (240) 276-0484

Director, Office of Surveillance and Biometrics

Susan Gardner (240) 276-3351

Center for Drug Evaluation and Research (CDER)

Director

Steven Galson (301) 594-5400

Deputy Director

Douglas Throckmorton (301) 594-5400

Associate Director for Safety Policy and Communications

Paul Seligman (301) 443-5620

Drug Safety Oversight Board

Susan Cummins (301) 443-5284

Associate Director for Medical Informatics

Randy Levin (301) 827-7784

Associate Director for Regulatory Policy

Jane Axelrad (301) 594-5400

Director, Office of Executive Programs

Jane Ware* (301) 443-5293

Director, Office of Management

Russell Abbott (301) 594-6741

Director, Office of Training and Communication

Nancy Smith (301) 827-1651

Director, Office of Information Technology

James Shugars (301) 827-6240

Director, Office of Counter-Terrorism and Pediatric Drug Development

Rosemary Roberts (301) 796-7210

Office of Translational Services

Director

Shirley Murphy (301) 796-2600

Director, Office of Clinical Pharmacology and Biopharmaceutics

Lawrence Lesko (301) 796-2450

Director, Office of Biostatistics

Robert O'Neill (301) 827-3195

Office of Compliance

Director

Deborah Autor (301) 827-8910

Deputy Director

Joe Famulare* (301) 827-8910

Director, Division of Scientific Investigations

Joseph Salewski (301) 594-0020

Chief, Good Clinical Practices Branch I

Ni Khin (301) 827-7395

Chief, Good Clinical Practices Branch II

Leslie Ball (301) 827-5455

Chief, GLP/Bioequivalence Investigations Branch

C.T. Viswanathan (301) 594-0163

Office of Medical Policy

Director

Robert Temple (301) 796-2270

Deputy Director

Rachel Behrman (301) 796-2270

Director, Division of Drug Marketing, Advertising, and Communications

Thomas Abrams (301) 796-1200

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

Robert Meyer (301) 796-2310

Director, Office of Drug Evaluation III

Julie Beitz (301) 796-0848

Director, Office of Antimicrobial Products

Mark Goldberger (301) 796-0720

Director, Office of Oncology Products

Richard Pazdur (301) 796-2340

Director, Office of Nonprescription Products

Charles Gamley (301) 796-2060

Office of Pharmaceutical Science

Director

Helen Winkle (301) 796-2400

Deputy Director

Keith Webber (301) 796-2400

Director, Office of New Drug Quality Assessment

Moheb Nasr (301) 796-1900

Director, Office of Generic Drugs

Gary Buehler (240) 276-9310

Director, Office of Testing and Research

Linda Bushe (314) 529-2134

Director, Office of Biotechnology Products

Steven Kozlowski (301) 796-2390

Office of Surveillance and Epidemiology

Director

Gerald Dal Pan (301) 796-2380

Center for Biologics Evaluation and Research (CBER)

Director

Jesse Goodman (301) 827-0372

Deputy Director, Medical

Karen Midthun (301) 827-0376

Associate Director for Policy

Diane Maloney (301) 827-0372

Associate Director for Research

Kathryn Carbone (301) 827-0377

Associate Director for Quality Assurance

Sheryl Lard-Whiteford (301) 827-0379

Associate Director for Review Management

Robert Yetter (301) 827-0373

Senior Policy Advisor and Counselor for Biologics

Jill Warner (301) 827-0372

Director, Office of Biostatistics and Epidemiology

Mary Foulkes (301) 827-3034

Director, Office of Communication, Training, and Manufacturers Assistance

Dennis Strickland* (301) 827-2000

Director, Office of Management

Joseph Biviano (301) 827-1320

Director, Office of Information Technology

Ginger Leo* (301) 827-1368

Director, Office of Blood Research and Review

Jay Epstein (301) 827-3518

Director, Office of Vaccines Research and Review

Norman Baylor (301) 827-0655

Director, Office of Cellular, Tissue, and Gene Therapies

Celia Witten (301) 827-6536

Director, Office of Compliance and Biologics Quality

Mary Anne Malarkey (301) 827-6190

Director, Division of Inspections and Surveillance

Gilliam Conley (301) 827-6220

Chief, Bioresearch Monitoring Branch

Patricia Holobaugh (301) 827-6220

*Acting

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