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.
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.