Applied Clinical Trials
A comprehensive listing of US departments and offices that includes the telephone numbers of directors, commissioners, and advisors.
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
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
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.