Applied Clinical Trials
A comprehensive listing of US departments and offices that includes the telephone numbers of directors, commissioners, and advisors.
Commissioner
Margaret Hamburg (301) 796-5000
Chief Counsel
Elizabeth Dickinson* (301) 796-8540
Counselor to the Commissioner
John M. Taylor (301) 796-7460
Chief of Staff
Molly Muldoon (301) 796-5000
Deputy Commissioner for Global Regulatory Operations and Policy
Deborah Autor (301) 796-8400
Deputy Commissioner for Medical Products and Tobacco
Stephen Spielberg (301) 796-5000
Deputy Commissioner for Foods
Michael Taylor (301) 796-4500
Associate Commissioner for Policy and Planning
David Dorsey (301) 796-4800
Associate Commissioner for Legislation
Jeanne Ireland (301) 796-8900
Chief Scientist and Deputy Commissioner for Science & Public Health
Jesse Goodman (301)796-9600
Director, Office of Science and Innovation
Vicki Seyfert-Margolis (301) 796-9605
Director, Office of Scientific Integrity
Luciana Borio (301) 796-9383
Director, Office of Critical Path Programs
Leonard Sacks* (301) 796-8490
Director, Office for Women's Health
Marsha Henderson* (301) 796-9440
Director, Office of Minority Health
Michelle Yeboah* (301) 796-4649
Director, National Center for Toxicological Research
William Slikker (870) 543-7000
Director, Center for Tobacco Products
Lawrence Deyton (877) 287-1373
Associate Commissioner for External Affairs
Virginia Cox (301) 796-4631
Director, Office of 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
Gayatri Rao* (301) 796-8662
Director
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
Associate Commissioner for Regulatory Affairs
Dara Corrigan (301) 796-8800
Deputy Associate Commissioner for Compliance Policy
Steven Solomon (301) 796-8800
Director Office of Regional Operations
David Elder (301) 443-6230
Director, Office of Enforcement
Howard Sklamberg (301) 796-8314
Director
Jeffrey Shuren (301) 796-5900
Deputy Director and Chief Scientist
William Maisel (301) 796-5900
Deputy Director for Policy
Nancy Stade (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
Matthew Tarosky* (301) 796-5490
Director, Office of In Vitro Diagnostic Device Evaluation and Safety
Alberto Gutierrez (301) 796-5453
Director, Office of Surveillance and Biometrics
Thomas Gross* (240) 796-5997
Director, Office of Science & Engineering Laboratories
Steven Pollack (301) 796-2530
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 Safety Operations
Theresa Toigo (301) 796-8460
Associate Director for Regulatory Policy
Jane Axelrad (301) 796-5400
Associate Director for Planning and Business Informatics
Theresa Mullin (301) 796-3800
Director, Office of Executive Programs
Deborah Henderson (301) 796-1446
Director, Office of Management
Melanie Keller (301) 796-3300
Director, Office of Communications
Julie Zawisza (301) 796-3700
Director, Office of Counterterrorism and Emergency Coordination
Rosemary Roberts (301) 796-2210
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
Director
Ilisa Bernstein* (301) 796-3100
Director
Leslie Ball (301) 796-3150
Deputy Director
Thomas Moreno (301) 796-2247
Associate Director for Risk Science, Intelligence and Prioritizing
Ann Meeker-O'Connell (301) 796-7615
Associate Director for Policy and Communication
Karena Cooper (301) 796-1612
Associate Director for Program Management and Organizational Strategy
Tanya Clayton (301) 796-0871
Associate Director for Bioequivalence and Good Laboratory Practice
CT Viswanathan (301) 796-3394
Director
Rachel Sherman (301) 796-2500
Deputy Director
Kathleen Uhl (301) 796-2500
Associate Director for Regulatory Affairs
Janet Norden (301) 796-2400
Director, Office of Prescription Drug Promotion
Thomas Abrams (301) 796-1200
Director Office of Medical Policy Initiatives
Denise Hinton (301) 796-1090
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 Drug Evaluation IV
Charles Ganley (301) 796-0895
Director, Office of Antimicrobial Products
Edward M. Cox (301) 796-1300
Director, Office of Hematology and Oncology Products
Richard Pazdur (301) 796-2340
Director
Helen Winkle (301) 796-2400
Director, Science and 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) 796-2400
Director, Office of Testing and Research
Vincent Vilker (301) 796-0200
Director, Office of Biotechnology Products
Steven Kozlowski (301) 796-2390
Director
Gerald DalPan (301) 796-2380
Deputy Director
Henry "Skip" Francis (301) 796-2380
Director
Karen Midthun (301) 827-0372
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) 827-0374
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
Senior Scientist for Emerging and Pandemic Threat Preparedness
David Cho (301) 827-6352
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 and Development
Lorrie McNeill (301) 827-2000
Director, Office of Management
James Sigg (301) 827-1320
Director, Office of Blood Research and Review
Jay Epstein (301) 827-3518
Director, Office of Vaccines Research and Review
Norman Baylor (301) 796-2630
Director, Office of Cellular, Tissue, and Gene Therapies
Celia Witten (301) 827-5102
Director, Office of Compliance and Biologics Quality
Mary Anne Malarkey (301) 827-6190
Director, Division of Inspections and Surveillance
Gilliam Conley (301) 827-6220
Director, Bioresearch Monitoring Branch
Patricia Holobaugh (301) 827-6220
Director
Jerry Menikoff (240) 453-6900
NIH Institutes, Center, and Divisions
Deputy Director and Director, Office of International Activities
Melody Lin (240) 453-8126
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
*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.