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(OCD) DIRECTOR Janet Woodcock, M.D. Executive Assistant Sharnell Ligon Deputy Director for Regulatory Programs Douglas C. Throckmorton, M.D. Deputy Center Director for Clinical Science Robert Temple, MD. Program Support Specialist Janice Shelton
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Associate Director for Planning and Business Informatics Theresa Mullin, Ph.D. 301-796-3422 Office Automation Assistant Kathleen Smith Drug Safety Oversight Board Steven Osborne, M.D. Project Specialist Georgiann Lenzl Associate Director for International Programs Justina A. Molzon, J.D. Ombudsman Virginia Behr Controlled Substance Staff Michael Klein, Ph.D. Supervisory Senior Management Officer Vacant OFFICE OF PHARMACEUTICAL SCIENCE (OPS) Director Helen Winkle Deputy Director
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Keith Webber Technical Information Specialist Vera Viehmann Director, Operations Staff Kerry Murphy Director, Science and Research Staff Nakissa Sadrieh, Ph.D. Director, New Drug Microbiology Staff David Hussong, Ph.D. Scientific Coordinator Russell Wesdyk, M.B.A. Associate Director for Policy Development Jon Clark OFFICE OF BIOTECHNOLOGY PRODUCTS (OBP) Director Steven Kozlowski, M.D. Deputy Director Vacant Associate Director of Medical Affairs Kenneth Hyams, M.D., M.P.H. Associate Director for Operations Marilyn Welschenbach, Ph.D. Management Officer James Selby, Jr.
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Division of Monoclonal Antibodies (DMA) Director Kathleen Clouse, Ph.D. Deputy Director Patrick Swann, Ph.D.
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OFFICE OF TESTING AND RESEARCH (OTR) Director Vincent Vilker, Ph.D. Deputy Director Vacant Associate Director for Research Policy Joseph Hanig Management Officer Derek Hicks (Acting) Management Specialist Geoff Salyer Laboratory of Clinical Pharmacology (LCP) Director Thomas Colatsky, Ph.D. (Acting)
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Division of Product Quality Research (DPQR) Director Mansoor Khan, Ph.D. Deputy Director Tasheen Mirza Division of Pharmaceutical Analysis (DPA) Director Lucinda F. Buhse, Ph.D.
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Technical Information Specialist Patricia Downs HFD-600 Deputy Director Robert West, R.Ph. Director for Science Lawrence Yu, Ph.D.
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Associate Director for Medical Affairs Dena Hixon, M.D. HFD-600 Associate Director for Chemistry Frank O. Holcombe, Jr., Ph.D. HFD-600
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Associate Director for Operations and Communications Rita Hassall, R.N. HFD-600 240-276-9310 Management Officer Patricia Littleton Division of Chemistry I (DCI) Director Paul Schwartz, PhD. (Acting) Deputy Director Vacant Division of Chemistry II (DCII) Director Glen Smith , Ph.D. (Acting) Deputy Director Glen Smith, Ph.D. (Acting) Division of Chemistry III (DCIII) Director Vilayat Sayeed, Ph.D.
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Division of Bioequivalence (DB) Director Dale Conner, Pharm.D. Deputy Director Barbara Davit, Ph.D.
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Deputy Director Vacant OFFICE OF NEW DRUG QUALITY ASSESSMENT (ONDQA) Director Moheb Nasr, Ph. D. Technical Information Specialist Patricia OConnor Deputy Director (Science and Policy) Christine Moore, Ph.D. Deputy Director (Review and Operations) Elaine Morefield
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Associate Director for Regulatory Science and Policy John Smith, Ph.D. 301-796-1757 Associate Director for Product Quality- Urgent Response Norm Schmuff, Ph.D. (Acting) 301-794-1454 Associate Director for Regulatory Affairs Michael Folkendt BioPharmaceutics Lead Patrick Marroum, PhD. Program Manager David Morley Management Officer Shanell Owens
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Division of New Drug Quality Assessment I (DNDQA I) Director Richard Lostritto, Ph.D. Branch Chief, Branch I Ramesh Sood, PhD.
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Branch Chief, Branch II Sarah Pop-Miksinski, Ph.D. Branch Chief, Branch III Hasmukh Patel, PhD.
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Division of New Drug Quality Assessment II (DNDQA II) Director Terry Ocheltree, PhD. Branch Chief, Branch IV Moo Jhong Rhee, PhD. Branch Chief, Branch V Rapti Madurawe Branch Chief, Branch VI Tom Oliver, PhD,
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Division Of New Drug Quality Assessment III (DNQAIII) Director Eric Duffy, Ph.D. Branch Chief, Branch VII Ali Al-Hakim, PhD. Branch Chief, Branch VIII Prasad Peri, PhD. Branch Chief, Branch IX Jim Vidra, PhD. OFFICE OF REGULATORY POLICY (ORP) Director Jane A. Axelrad, J.D. Deputy Associate Director for Policy Denise Esposito
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Special Assistant Michael D. Jones Management Officer Michelle Bacon Program Support Specialist Paula Fidel-Aitken Division of Regulatory Policy I (DRPI) Director Nancy Boocker, J.D. Division of Regulatory Policy II (DRPII) Director Michael Bernstein, J.D. Division of Regulatory Policy III (DRPIII) Director Nam Kim, J.D.
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Division of Information Disclosure Policy (DIDP) Director Nancy Sager OFFICE OF EXECUTIVE PROGRAMS (OEP) Director Deborah Henderson Deputy Director Jayne Ware Directors Secretary Breana McLaren Executive Operations Staff Christine Bechtel Advisors and Consultants Staff Jayne Peterson Management Officer Melanie Whalen OFFICE OF MANAGEMENT (OM)
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Director Melanie Keller Secretary Jeff Kuti Deputy Director Edwin Echgoyen Management Officer Rebecca E. Glidden Division of Management and Budget (DMB) Director Rixie Scott Deputy Director Katie Green Planning and Resource Management Branch Kevin Laser HFD-050 Management Analysis Branch Don Kim
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Division of Management Services (DMS) Director Mary Milline Deputy Director Tania Tse
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Interface Management Branch (IMB) Thomas Murphy HFD-067 OFFICE OF NEW DRUGS (OND) Director John Jenkins, M.D. Executive Assistant Victor Vail Deputy Director
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Senior Management Officer, Program Management Analysis Staff Eldridge Coles 301-796-0141 WO 22/Rm. 6418 Associate Director, Pharmacology and Toxicology David Jacobson-Kram, Ph.D., D.A.B.T. 301-796-0175 Associate Director, Regulatory Affairs Lina AlJuburi, PharmD. (Acting)
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Associate Director, Study Endpoints & Labeling Development CAPT. Laurie Burke, R.Ph., M.P.H 301-796-0900 Associate Director, Pediatric & Maternal Health Staff Lisa Mathis, M.D. 301-796-2200 Associate Director, Guidance/Policy Team Sally Loewke, M.D. Associate Director, Rare Disease Program Anne Pariser, MD. Associate Director, Biosimilars Program Leah Christl, PhD.
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Associate Director, Learning and Career Development Susanne Walker 301-796-5229 Associate Director, Safety Policy and Research Mwango Kashoki, MD. 301-796-1238
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OFFICE OF DRUG EVALUATION I (ODEI) Director Robert J. Temple, M.D. (Acting) Assistant Aprile Blount Deputy Director Dr. Ellis Unger Associate Director for Regulatory Affairs Colleen LoCicero Management Officer Andrea Ferentinos
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Director Norman Stockbridge, M.D., Ph.D. Deputy Director Stephen Grant, M.D. Supervisory Project Manager Edward Fromm Division of Neurology Products (DNP) Director Russell G. Katz, M.D. Deputy Director Eric Bastings, M.D. Supervisory Project Manager Robbin Nighswander, R.Ph. Jacqueline Ware, R.Ph.
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Division of Psychiatry Products (DPP) Director Thomas Laughren, M.D. Deputy Director Mitchell Mathis, M.D. Supervisory Project Managers Steven Hardeman, R.Ph. Paul David, R.Ph. OFFICE OF DRUG EVALUATION II (ODEII) Director Curtis Rosebraugh, M. D. Secretary Velma Cunningham Deputy Director Vacant Associate Director for Regulatory Affairs Leah Ripper Management Officer
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Thomas Cunningham
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Division of Metabolism and Endocrinology Products (DMEP) Director Mary Parks, M.D. Deputy Director Eric Colman, M.D. Supervisory Project Managers Enid M. Galliers Lina Aljuburi
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Division of Pulmonary and Allergy Products (DPAP) Director Badrul Chowdhury, M.D. Deputy Director Lydia Gilbert-McClain, M.D. Supervisory Project Manager Sandra L. Barnes
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Division of Analgesics, Anesthetics, and Rheumatology Products (DAARP) Director Bob A. Rappaport, M.D. Deputy Director Sharon Hertz, M.D. Deputy Director Rigoberto Roca, M.D. Supervisory Project Managers Parinda Jani Sara Stradley OFFICE OF DRUG EVALUATION III (ODEIII) Director Julie Beitz, M.D. Program Support Specialist Diane Thomas
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Deputy Director Vacant Associate Director for Regulatory Affairs Maria Walsh Management Officer Antoinette Mason
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Division of Reproductive and Urologic Products (DRUP) Director Scott Monroe, M.D. Deputy Director George Benson, M.D. Supervisory Project Managers Margaret Kober Jennifer Mercier
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Division of Gastroenterology Products (DGP) Director Donna Griebel, M.D. Deputy Director Andrew Mulberg Supervisory Project Managers Richard Wes Ishihara Brian Strongin
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Division of Dermatology and Dental Products (DDDP) Director Susan Walker, M.D. Deputy Director Stanka Kukich, M.D. Supervisory Project Manager Barbara Jean Gould
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OFFICE OF ANTIMICROBIAL PRODUCTS (OAP) Director Edward Cox, M.D., M.P.H. Deputy Director
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Associate Director for Regulatory Affairs David Roeder Management Officer Dana Schuhly Division of Anti-Infective Products (DAIP) Director John Farley, M.D., M.P.H. Deputy Director Katherine Laessig, M.D. Supervisory Project Managers Frances LeSane Maureen Dillon-Parker Division of Anti-Viral Products (DAVP) Director Debra Birnkrant, M.D. Deputy Director Jeffrey Murray, M.D., MPH Supervisory Project Managers Victoria Tyson Karen Winestock
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Division Transplant and Ophthalmology Products (DTOP) Director Renata Albrecht, M.D. Deputy Director Wiley A. Chambers, M.D. Supervisory Project Manager Diana Willard Supervisory Project Manager Judit Milstein OFFICE OF DRUG EVALUATION IV (ODEIV) Director Charles J. Ganley, M.D.
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Secretary Norma Jiggetts Deputy Director Shaw T. Chen, M.D. Associate Director for Regulatory Affairs Vacant Associate Director Susan Johnson, Pharm.D., Ph.D.
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Division of Nonprescription Clinical Evaluation (DNCE) Director Andrea Leonard-Segal, M.D. Deputy Director Joel Schiffenbauer, M.D. Program Specialist Pamela Hampton (Acting)
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Division of Nonprescription Regulation Development (DNRD) Director M. Scott Furness, Ph.D. Deputy Director Debbie Lumpkins Program Specialist (Acting) Merla Rae Matheny
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Division of Medical Imaging Products (DMIP) Director Rafel (Dwaine) Rieves, M.D. Secretary Vacant Deputy Director Libero Marzella, M.D. Supervisory SCO Kyong Kang
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OFFICE OF HEMATOLOGY AND ONCOLOGY PRODUCTS (OHOP) Director Richard Pazdur, M.D. Project Specialist Bertha Mejia Deputy Director Vacant Associate Director for Regulatory Affairs Tamy Kim (Acting) Associate Director for Regulatory Science Anthony Murgo, M.D. Management Officer Krista Yazdani Division of Oncology Products (DOP 1) Director Robert Justice, MD. Secretary Temitayo Lewis Deputy Director Amna Ibrahim, MD. Supervisory CSO Frank Cross Alice Kacuba Division of Oncology Products (DOP 2) Director Patricia Keegan, MD. Secretary Barry Littleton Deputy Director Joseph Gootenberg, MD. Supervisory CSO
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Karen Jones Division of Hematology Products (DHP) Director Ann Farrell, M.D. Secretary Vacant Deputy Director Edvardas Kaminskas, M.D. (Acting) Supervisory CSO Janet Jamison
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Division of Hematology Oncology Toxicology Products (DHOT) Director John Leighton (Acting) Secretary Vacant Deputy Director Vacant OFFICE OF SURVEILLANCE AND EPIDEMIOLOGY (OSE) Director Gerald Dal Pan, M.D., M.H.S. (Acting) Program Support Specialist Barbara M. McCary Deputy Director Henry Francis, M.D. (Acting) Supervisory Senior Management Officer Amy Garvin Outreach Staff Director Cheryl Campbell Project Management Staff (PMS) Staff Director Sammie Beam (Acting)
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Office of Pharmacovigilance & Epidemiology (OPE) Director Gerald Dal Pan, M.D., M.H.S Deputy Director Henry Frances, M.D. Division of Pharmacovigilance I (DPV I) Director Linda Scarazzini Deputy Director Vacant
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Division of Pharmacovigilance II (DPV II) Director Vacant Deputy Director Bindi Nikhar, M.D. Division of Epidemiology (DEPI) Director Solomon Iyasu, M.D., M.P.H. Deputy Director Tarek Hammad, MD. Division of Epidemiology II (DEPI II) Director Judy Staffa, Ph.D. Deputy Director Laura Governale
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Office of Medication Error Prevention and Risk Management (OMEPRM) Director Vacant Deputy Director Vacant Division of Risk Management (DRISK)
Director Claudia Karwoski, Pharm. D. Deputy Director Mary Willy, Pharm. D. (Acting)
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Division of Medication Errors Prevention and Analysis (DMEPA) Director Carol Holquist, R.Ph. Deputy Director Vacant OFFICE OF TRANSLATIONAL SCIENCES (OTS) Director ShaAvhree Buckman, M.D., Ph.D., F.A.A.P. Program Support Specialist Kiesha Houston Deputy Director Susan McCune (Acting) Supervisory Senior Management Officer Raya S. McCree Associate Director for Regulatory Affairs Rubynell Jordan, BSN, MPA Research Coordinator CAPT Frances T. Gipson Associate Director for Science Jan Johannessen OFFICE OF BIOSTATISTICS (OB) Director Robert ONeill, Ph.D. Program Support Specialist Shereese Johnson (Acting) Deputy Director Edward Nevius, Ph.D. Associate Director Sue Jane Wang, Ph.D.
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Associate Director for Statistical Science & Policy Ram Tiwari 301-796-4084 Management Officer Lisa Gilmer Division of Biometrics I (DBI) Director James Hung, Ph.D. Deputy Director Kooros Mahjoob, Ph.D. Division of Biometrics II (DBII) Director Thomas Permutt, Ph.D. Deputy Director Jon Sahlroot Division of Biometrics III (DBIII) Director Stephen Wilson, Ph.D. Division of Biometrics IV (DBIV) Director Mohammad Huque, Ph.D. Deputy Director Daphne Lin, Ph.D. Division of Biometrics V (DBV) Director Aloka G. Chakravarty, Ph.D. Deputy Director Rajeshwari Sridhara Division of Biometrics VI (DBVI) Director Stella Machado, Ph.D. Deputy Director Yi Tsong
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OFFICE OF CLINICAL PHARMACOLOGY (OCP) Director Lawrence J. Lesko, Ph.D. Program Support Specialist Karen Graves Deputy Director Shiew-Mei Huang, Ph.D. Associate Director of Genomics Issam Zineh, Pharm.D. Pharmacometrics Staff Jogarao Gobburu, Ph.D. Management Officer Malcom Dennis Division of Clinical Pharmacology I (DCPI) Director Mehul Mehta, Ph.D. Deputy Director Ramana S. Uppoor Division of Clinical Pharmacology II (DCPII) Director Chandra Sahajwalla Deputy Director Suresh Doddapaneni
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Division of Clinical Pharmacology III (DCPIII) Director Dennis Bashaw, Ph.D. Deputy Director Hae Young Ahn
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301-796-1494
WO 51/Rm. 3132
Division of Clinical Pharmacology IV (DCPIV) Director John A. Lazor, Pharm.D. Deputy Director Kellie Reynolds
301-796-1559
WO 51/Rm. 2134
301-796-1594
WO 51/Rm.2142
Division of Clinical Pharmacology V (DCPV) Director Atik Rahman, Ph.D. Deputy Director Brian Booth OFFICE OF MEDICAL POLICY (OMP) Director Rachel E. Sherman, M.D. Assistant Laura Myers Deputy Director Kathleen Uhl, M.D. Associate Director for Regulatory Affairs Janet Norden Senior Management Officer Tammy Russell Office of Prescription Drug Promotion Director Thomas W. Abrams, RPh, MBA Deputy Director Vacant Division of Direct of-Consumer Promotion Director Vacant Deputy Director Vacant Division of Professional Promotion Director Vacant Deputy Director Vacant Office of Medial Policy Initiative
301-796-1591
WO 51/Rm. 2188
301-796-1508
WO 51/Rm. 2186
301-796-2500
WO 51/Rm. 6338
301-796-2500
WO 51/Rm. 6337
301-796-2500
WO 51/Rm. 6342
301-796-2500
WO 51/Rm. 6324
301-796-2500
WO 51/Rm. 6332
301-796-1200
WO 51/Rm. 3264
Director CMDR Denise M. Hinton Deputy Director Vacant Associate Director for Regulatory Affairs Melissa Robb Division of Medical Policy Development Director Paula McKeever Deputy Director Vacant Division of Medical Policy Programs Director CMDR Richardae Araojo Deputy Director Vacant
301-796-1090
WO 51/Rm. 6348
301-796-5227
WO 51/Rm. 6360
301-796-8499
WO 51/Rm. 6358
301-796-1152
WO 51/Rm. 2218
OFFICE OF PLANNING & INFORMATICS (OPI) Director Theresa Mullin, Ph.D. Deputy Director Mary Ann Slack Executive Assistant Angela Kwon Supervisory Senior Management Officer Maria Andrews Office of Planning & Analysis (OPA) Director Theresa Mullin, Ph.D. (Acting) Management Officer Kathleen Tchoulakian Analysis Staff (AS) Staff Director 301-796-3800 WO 51/Rm. 1178
301-796-0603
WO 51/Rm. 1188
301-796-4957
WO51/Rm. 1183
301-796-2273
WO 51/Rm. 1184
301-796-3800
WO51/Rm. 1178
301-796-0570
WO 51/Rm. 1195
Marta Wosinska, Ph.D. Planning & Evaluation Staff (PES) Staff Director Sunanda Bahl Office of Business Informatics (OBI) Director Hilmar Hamann, PhD. Deputy Director Gary Gensinger Administrative Assistant Julie Quinonez
301-796-3673
WO 51/Rm. 1186
301-796-3584
WO 51/Rm. 1162
301-796-1000
WO 22/Rm. 1124
301-796-0589
WO 22/Rm. 1112
301-796-0282
WO 22/Rm. 1135
301-796-2112
WO 22/Rm. 1122
Computations Science Center Support Team Technical Architect Binh Ta Division of Project Development (DPD) Division Director Linda Sigg
301-796-4010
WO 22/Rm. 1128
301-796-0625
WO 22/Rm. 1114
Business Informatics Collaboration Team (BICT) William Taylor 301-796-0628 Business Analysis Requirement Team (BART) Amy Gomez 301-796-0322 Division of Business Analysis & Reporting (DBAR) Division Director Yashika Rahaman Reports Management Team (RMT) Michael Cu Data Retrieval and Analysis Team (DRAT) Nancy Maizel
WO 22/Rm. 1175
WO 22/Rm. 1123
301-796-3843
WO 22/Rm. 1110
301-796-0582
WO 22/Rm. 1237
301-796-0607
WO 22/Rm. 1209
Division Director Mark Gray eSubmission Support Team (eSST) Virginia Hussong eReview Support Team (eRST) Samantha Gordon
301-796-2081
WO 22/Rm. 1132
301-796-1016
WO 22/Rm. 1161
301-796-4894
WO22/Rm. 1219
Division of Records Management (DRM) Division Director Gary Gensinger (Acting) Records Management Team (RMT) Franklin Stephenson
301-796-0589
WO 22/Rm. 1112
301-796-3872
WO 22/Rm. 1189
Document Room Management Team (DRMT) Mia Prather 301-796-0618 OFFICE OF COMMUNICATIONS (OCOMM) Director Julie Zawisza Program Support Specialist Brenda Adams Deputy Director Kimberly Rawlings Management Officer Kelly Phelan
WO 22/Rm. 1133
301-796-3700
Hillandale/Rm. 1126
301-796-2015
Hillandale/Rm. 1124
301-796-3818
Hillandale/Rm. 1146
301-796-3176
Hillandale/Rm. 1144
Division of Training and Development (DTD) Moved to OEP Director Janice Newcomb Deputy Director Virginia Giroux Division of Public Affairs (DPA) Director Anthony E. Sims (Acting) Project Specialist
301-796-3178
WO 51/Rm. 2358
301-796-3179
WO 51/Rm. 2362
301-796-3121
Paul G Neff Deputy Director Anthony E. Sims Division of Drug Information (DDI) Director Barry Poole Deputy Director Mary Kremzner Division of Information Services (DIS) Director Paul Buckman Deputy Director Sally Winthrop OFFICE OF COMPLIANCE (OC) Director Ilisa Bernstein, PharmD., JD. (Acting) Executive Assistants Marlene Sue Ling William Harris Paula Simmons Deputy Director for Program Operations Jennifer Devine, JD. (Acting) Deputy Director for Policy & Analysis Douglas Stearn, Esq.
301-796-3123
Hillandale/Rm. 4168
301-796-3126
Hillandale/Rm. 4170
301-796-3145
Hillandale/Rm. 4130
301-796-3144
Hillandale/Rm. 4150
301-796-3135
Hillandale/Rm. 1106
301-796-3135
Hillandale/Rm. 1122
301-796-4723
WO 51/Rm. 5270
301-796-3363
WO 51/Rm. 5266
301-796-3100
WO 51/Rm 5276
Associate Director of Scientific and Medical Affairs Vacant Associate Director for Risk Science, Intelligence & Prioritizing H. Gregg Claycamp, M.S., Ph.D. (Acting) 301-796-3130 Associate Director of Organizational Strategy Kristi Hampton-Thurston (Acting) 301-796-3238 Senior Advisor Vacant Associate Director for Business Administration Collin Figueroa 301-796-5802
WO 51/Rm. 4266
WO 51/Rm. 5276
WO 51/Rm 1142
Lead Management Officer Karen Kirchberg Contract Specialist Joan Ginetis Regulatory Counsels Meredith Francis, Esq. Harry Schwirck, Esq. Ann Metayer, Esq. Senior Communications Advisor Judy Leon Project Management Officers George Smith Milinda Soukup Brenda Woods-Francis Executive Communications Team Kim Brown Margaret Cole Senior Advisor for Regulatory Science Vacant
301-796-3233
WO 51/Rm. 4274
301-796-4624
WO 51/Rm. 5250
301-796-4624
WO 51/Rm. 5250
301-796-4292 301-796-3966
Office of Unapproved Drugs and Labeling Compliance (OUDLC) Director Kathleen Anderson, PharmD. (Acting)
301-796-3309
WO 51/Rm. 5182
Associate Director for Policy and Communication Gail Bormel (Acting) 301-796-3263
WO 51/Rm. 5186
Associate Director for Program Management and Organizational Strategy Akilah Green (Acting) 301-796-1219 WO 51/Rm. 5166 Associate Director for Risk Science, Intelligence and Prioritization Meghan Murphy (Acting) 301-796-3307
WO 51/Rm. 5178
Senior Medical Advisor Charlie Lee Senior Advisor Bob Heller (Acting) Project Management Officers Alisea Crowley
301-796-1244
WO 51/Rm. 5184
301-796-3353
WO 51/Rm. 5246
301-796-1144
WO 51/Rm. 5196
WO 51/Rm. 5176
Over the Counter Drugs Branch Anuj Shah (Acting) Health Fraud and Consumer Outreach Branch Vacant Health Fraud and Consumer Outreach Team Brad Pace (Acting Team Leader) Division of Prescription Drugs Judy McMeekin (Acting) Prescription Drugs Branch Sakineh Walther (Acting)
301-796-2246
WO51/Rm. 5104
301-796-3538
WO 51/Rm. 5171
301-796-3344
WO 51/Rm. 5237
301-796-3349
WO 51/Rm. 5242
WO 51/Rm. 5171
Marketed Unapproved Drugs-Regulatory Status & Labeling Team Kim Simmons (Acting) 301-796-3684 WO 51/Rm. 4212 Compounding and Pharmacy Practices Branch Vacant Compounding and Pharmacy Practice Team Ian Deveau (Acting)
301-796-5061
WO 51/Rm. 5198
Office of manufacturing and Product Quality (OMPQ) Director Steve Lynn (Acting) Deputy Director Michael Smedley (Acting)
301-796-3315
WO 51/Rm. 4360
301-796-3273
WO 51/Rm. 4348
Associate Director for Program Management & Organizational Strategy Kennerly K. Chapman 301-796-3271 WO 51/Rm. 4346 Associate Director for Risk Science Intelligence & Prioritization Rick Friedman (Acting) 301-796-3268 Associate Director for Policy & Communication Brian Hasselbalch (Acting) 301-796-3279 Associate Director for Drug Quality Assurance Vacant Senior Advisor Helen Saccone (Acting) Project Management Officers (co-located)
WO 51/Rm. 4342
WO 51/Rm. 4364
301-796-3647
WO 51/Rm. 5283
Kennerly Chapman Helen Saccone, PharmD. Keith Olin, PharmD. Regulatory Counsel H. Joy Sharp
301-796-3647
WO 51/Rm. 4326
301-796-3281
WO 51/m. 4372
New Drug Manufacturing Assessment Branch Branch Chief Davud Doleski (Acting) 301-796-2627 Generic Drug Manufacturing Assessment Branch Branch Chief Concepcion Cruz (Acting) 301-796-3254 Biotech Manufacturing Assessment Branch Branch Chief Patricia Hughes (Acting)
WO 51/Rm. 4372
WO 51/Rm. 4316
301-796-3189
WO 51/Rm. 4328
Division of Domestic Drug Quality Director Teddi Lopez (Acting) Domestic Compliance Branch 1 Branch Chief Vacant Domestic Compliance Branch 2 Branch Chief David Jaworski (Acting) Division of International Drug Compliance Director Carmelo Motta (Acting) International Compliance Branch 1 Branch Chief Rosa Motto (Acting) International Compliance Branch 2 Branch Chief Vacant
301-796-3255
WO 51/Rm. 4368
301-796-3192
WO 51/Rm. 4242
301-796-3367
WO 51/Rm. 4240
301-796-3283
WO 51/Rm. 4368
Vacant Regulatory Policy & Collaboration Branch Branch Chief Grace McNally (Acting) Drug Surveillance & Data Reporting Branch Branch Chief Elise Murphy (Acting) Drug Quality Reporting System Direct Line
301-796-3286
WO 51/Rm. 4374
301-796-7565
WO 51/Rm. 4272
301-796-3140
Office of Scientific Investigations (OSI) Director Leslie Ball, M.D. (Acting) Deputy Director Thomas Moreno (Acting)
301-796-3150
WO 51/Rm. 5342
301-796-2247
WO 51/Rm. 5278
Associate Director for Risk Science, Intelligence & Prioritizing Ann Meeker- OConnell (Acting) 301-796-7615 Associate Director for Policy and Communication Karena Cooper (Acting) 301-796-1612
WO 51/Rm. 5339
WO 51/Rm. 5252
Associate Director for Program Management and Organizational Strategy Tanya Clayton (Acting) 301-796-0871 WO 51/Rm. 2224 Division of Safety Compliance Kevin Prohaska (Acting) Post Market Safety Branch Suzanne Barone (Acting) Human Subject Protection Branch Pay McNeilly (Acting) Div. of Good Clinical Practice Compliance Tejashri Purohit-Sheth, M.D. (Acting)
301-796-3707
WO 51/Rm. 5356
301-796-3224
WO 51/Rm. 4258
301-796-2947
WO 51/Rm. 2266
301-796-3402
WO 51/Rm. 5358
Good Clinical Practice Branch Enforcement Branch Constance Lewin, MD. (Acting) 301-796-3397 Good Clinical Practice Assessment Branch Jean Mulinde (Acting)
WO 51/Rm. 5354
301-796-0768
WO 51/Rm. 5318
Div. of Good Laboratory Practice and Bioequivalence Investigations Joseph Salewski (Acting) 301-796-3395 WO 51/Rm 5348 Associate Director for Bioequivalence & Good Laboratory Practice CT Viswanathan, PhD. 301-796-3394 WO 51/Rm. 5346 Bioequivalence Branch Sam Haidar Good Laboratory Practice Team Charles Bonapace (Acting)
301-796-4777
WO 51/Rm. 5330
301-796-1507
WO 51/Rm. 5228
OFFICE OF COUNTER-TERRORISM AND EMERGENCY COORDINATION (OCTEC) Director Rosemary Roberts, M.D. Deputy Director Brad Leissa, M.D. Management Analyst Pilar Martinez Program Support Specialist Vacant Assoc. Dir. Emergency Risk Communication Thomas J. Christle
301-796-2210
WO 51/Rm. 3342
301-796-2210
WO 51/Rm. 3348
301-796-1756
WO 51/Rm. 3346
301-796-2057
WO 51/Rm. 3358
Associate Director of Emergency Coordination Susan McDermott, M.D. 301-796-1121 Associate Director for Regulatory Affairs Joanne Holmes, R.Ph. Management Officer Karen D. Smith
WO 51/Rm. 3362
301-796-1681
WO 51/Rm. 3352
301-796-1756
WO 51/Rm. 3334