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.
Citius Pharmaceuticals Resubmits BLA to FDA for Lymphir to Treat Cutaneous T-Cell Lymphoma
March 19th 2024Pivotal Phase III Study 302 trial data show an objective response rate of 36.2% based on an independent review committee assessment in the treatment of relapsed/refractory cutaneous T-cell lymphoma.