Applied Clinical Trials
A comprehensive listing of U.S. departments and offices that includes the telephone numbers of directors, commissioners, and advisors.
Director
Bernard Schwetz (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
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 International and Special Programs
Murray Lumpkin (301) 827-5709
Deputy Commissioner for Medical and Scientific Affairs
Scott Gottlieb (301) 827-9776
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
Norris Alderson (301) 827-3340
Assistant Commissioner for Science
Linda Tollefson (301) 827-3340
Associate Commissioner for External Relations
Jason Brodsky* (301) 827-3330
Associate Commissioner for Planning
Theresa Mullin (301) 827-5292
Associate Commissioner, Office of International Programs
Melinda Plaisier (301) 827-4480
Associate Commissioner for Management
Kathleen Heuer (301) 255-6762
Associate Commissioner for Crisis Management
Ellen Morrison (301) 827-5660
Assistant Commissioner for Counterterrorism Policy
Boris Lushniak (301) 827-4067
Assistant Commissioner for Special Health Issues
Theresa Toigo (301) 827-4460
Director, Office of Orphan Products Development
Marlene Haffner (301) 827-3666
Director, Office of Pediatric Therapeutics
Dianne Murphy (301) 827-9218
Director, Office of Combination Products
Mark Kramer (301) 427-1934
Senior Advisor for Clinical Science and Director, Good Clinical Practice Program
David Lepay (301) 827-3340
Special Assistant to the Director
Patricia Beers Block (301) 827-3340
Associate Director for Bioresearch Monitoring
Stan Woollen (301) 827-3340
Associate Director for Human Subject Protection Policy
Bonnie Lee (301) 827-3340
Expert Consumer Safety Officer
Carolyn Hommel (301) 827-3340
Associate Commissioner for Regulatory Affairs
Margaret Glavin (301) 827-3101
Senior Advisor for Clinical Science
Lori Love (301) 827-3684
Director
Daniel Schultz (301) 827-7975
Deputy Director
Linda Kahan (301) 827-7975
Director, Office of Device Evaluation
Donna Bea Tillman (301) 594-2022
Director, Office of Compliance
Timothy Ulatowski (301) 276-0100
Director, Division of Bioresearch Monitoring
Michael Marcarelli (301) 276-0125
Director
Steven Galson (301) 594-5400
Deputy Director
Douglas Throckmorton (301) 594-5400
Scientific Advisor
Donald Stanski (301) 827-5443
Associate Director for Medical Informatics
Randy Levin (301) 827-7784
Associate Director for Regulation and Policy
Jane Axelrad (301) 594-5400
Director, Office of Executive Programs
Deborah Henderson (301) 594-5400
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
Margo Burnette (301) 827-6240
Director, Office of Counter-Terrorism and Pediatric Drug Development
Rosemary Roberts (301) 827-7777
Director, Office of Compliance
Joseph Famulare (301) 827-8910
Director, Office of Clinical Pharmacology and Biopharmaceutics
Lawrence Lesko (301) 594-5690
Director
Robert Temple (301) 796-2270
Deputy Director
Rachel Behrman (301) 796-2270
Director, Division of Scientific Investigations
Joanne Rhoades (301) 594-0020
Deputy Director
Joseph Salewski (301) 594-0020
Chief, Good Clinical Practices Branch I
Ni Khin (301) 594-1026
Chief, Good Clinical Practices Branch II
Leslie Ball (301) 594-1032
Chief, GLP/Bioequivalence Investigations Branch
C.T. Viswanathan (301) 594-0163
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
Florence Houn (301) 796-2100
Director, Office of Antimicrobial Products
Mark Goldberger (301) 796-1300
Director, Office of Oncology Products
Richard Pazdur (301) 796-2340
Director, Office of Nonprescription Products
Charles Gamley (301) 796-2060
Director
Helen Winkle (301) 594-2847
Deputy Director
Keith Webber* (301) 594-2847
Director, Office of New Drug Quality Assessment
Moheb Nasr (301) 827-5918
Director, Office of Generic Drugs
Gary Buehler (301) 827-5845
Director, Office of Testing and Research
Vacant (301) 827-2847
Director, Office of Biotechnology Products
Steven Kozlowski (301) 443-5089
Director
Paul Seligman (301) 827-6276
Deputy Director
Jonca Bull (301) 827-6276
Director, Office of Drug Safety
Gerald Dal Pan (301) 827-6276
Director, Office of Biostatistics
Robert O'Neill (301) 827-3195
Director
Jesse Goodman (301) 827-0372
Deputy Director for Medicine
Karen Midthun (301) 827-0378
Associate Director for Policy
Diane Maloney (301) 827-0373
Associate Director for Research
Kathryn Carbone (301) 827-0377
Associate Director for Medical and International Affairs
(vacant) (301) 827-0641
Associate Director for Quality Assurance
Sheryl Lard-Whiteford (301) 827-0379
Associate Director for Review Management
Robert Yetter (301) 827-9418
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
Mary Meyer (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 Couley (301) 827-6221
Chief, Bioresearch Monitoring Branch
Patricia Holobaugh (301) 827-6220
*Acting
Director
Elias Zerhouni (301) 496-2433
Deputy Director
Raynard Kington (301) 496-7322
Office of Extramural Research, Acting Deputy Director
Norka Brave (301) 496-1096
Office of Intramural Research, Deputy Director
Michael Gottesman (301) 496-1921
Office of Technology Transfer (OTT), Director
Bonny Harbinger (301) 404-7700
Office for Research on Women's Health (ORWH)
(301) 402-1770
Office of AIDS Research (OAR)
(301) 496-0357
National Cancer Institute (NCI)
(301) 496-6641
National Eye Institute (NEI)
(301) 496-5248
National Heart, Lung, and Blood Institute (NHLBI)
(301) 496-4236
National Human Genome Research Institute (NHGRI)
(301) 402-0911
National Institute on Aging (NIA)
(301) 496-1752
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
(301) 443-3860
National Institute of Allergy and Infectious Diseases (NIAID)
(301) 402-1663
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
(301) 496-8190
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
(301) 451-4772
National Institute of Child Health and Human Development (NICHD)
(301) 496-5133
National Institute on Deafness and Other Communication Disorders (NIDCD)
(301) 496-7243
National Institute of Dental and Craniofacial Research (NIDCR)
(301) 496-4261
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
(301) 496-3583
National Institute on Drug Abuse (NIDA) (301) 443-1124
National Institute of Environmental Health Sciences (NIEHS)
(919) 541-3345
National Institute of General Medical Sciences (NIGMS)
(301) 496-7301
National Institute of Mental Health (NIMH)
(301) 443-4536
National Institute of Neurological Disorders and Stroke (NINDS)
(301) 496-5751
National Institute of Nursing Research (NINR)
(301) 496-0207
National Library of Medicine (NLM)
(301) 496-6308
Warren Grant Magnuson Clinical Center (CC)
(301) 496-2563
Center for Information Technology (CIT)
(301) 496-6203
National Center for Complementary and Alternative Medicine (NCCAM)
(301) 594-7790
National Center for Research Resources (NCRR)
(301) 435-0888
National Center on Minority Health and Health Disparities (NCMHD)
(301) 435-3481
John E. Fogarty International Center (FIC)
(301) 496-2075
Visitor Information Center
(301) 496-1776
FDA Fast Tracks Johnson & Johnson’s Nipocalimab for Fetal Neonatal Alloimmune Thrombocytopenia
March 27th 2024Johnson & Johnson is moving forward with a pair of Phase III trials of nipocalimab to reduce the risk of fetal neonatal alloimmune thrombocytopenia in alloimmunized pregnant patients.