OR WAIT null SECS
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Applied Clinical Trials
Washington editor Jill Wechsler provides an updated list of U.S. regulatory agency personnel.
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
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
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
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
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
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
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
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
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
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
Director
Gerald Dal Pan (301) 796-2380
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