CENTER FOR DRUG EVALUATION AND RESEARCH KEY OFFICIALS

April 10, 2018

OFFICE OF THE CENTER DIRECTOR (OCD)

DIRECTOR Janet Woodcock, M.D. 301-796-5400 WO 51/Rm. 6133

Executive Assistant to Dr. Woodcock Sharnell Ligon 301-796-5400 WO 51/Rm. 6131

Special Assistant to Dr. Woodcock Devota DeMarco 301-796-3605 WO 51/Rm. 6124

Deputy Director Regulatory Programs Douglas C. Throckmorton, M.D. 301-796-5400 WO 51/Rm. 6132 Executive Assistant to Dr. Throckmorton Wynnet Green 301-796-1103 WO 51/Rm. 6128 Deputy Director Clinical Science Robert J. Temple, M.D. 301-796-2270 WO 22/Rm. 4212

Executive Assistant to Dr. Temple Aprile Blount 301-796-1079 WO 22/Rm. 4221 Special Assistant to Dr. Temple Melina Griffs 301-796-1078 WO 22/Rm. 4206 Deputy Director Science Operations Vacant Executive Assistant to Deputy Director Science Operations LaToya Richardson 240-402-4037 WO 51/Rm. 6126 Associate Director Drug Safety Operations

Theresa Toigo, R.Ph., M.B.A. 301-796-8473 WO 51/Rm. 6156 Associate Director for Compounding Julie Dohm 301-796-8732 WO 51/RM. 6140 Project Manager Georgiann Lenzi 301-796-3515 WO 51/Rm. 5159

Controlled Substance Staff (CSS) Director Dominic Chiapperino (Acting) 301-796-1183 WO 51/Rm. 5148 Professional Affairs and Stakeholder Engagement Staff (PASES) Director

John J. Whyte, M.D. M.Ph. 240-402-4121 WO 51/Rm. 2342 Counter-Terrorism and Emergency Coordination Staff (CTECS) Director Rosemary Roberts, M.D. 301-796-1740 Hillandale/Rm. 2128 Drug Shortage Staff (DSS) Director Valerie Jensen 301-796-0737 WO 22/Rm. 6204

OFFICE OF REGULATORY POLICY (ORP) DIRECTOR Grail Sipes, J.D. 301-796-5122 WO 51/Rm. 6244

Deputy Director Carol Bennett, J.D. 301-796-0037 WO 51/Rm. 6276

Executive Assistant Laura DeGrouchy 301-796-3632 WO 51/Rm. 6269

Administrative Management Team

Senior Manager Officer Kelley Hill 301-796-3706 WO 51/Rm. 6252

Division of Regulatory Policy I (DRPI) Director Nancy Hayes, J.D. 301-796-5211 WO 51/Rm. 6244 Division of Regulatory Policy II (DRPII) Director Michael Bernstein, J.D. 301-796-3478 WO 51/Rm. 6240 Division of Regulatory Policy III (DRPIII) Director Nam Kim, J.D. 301-796-3472 WO 51/Rm. 6320 Division of Regulatory Policy IV (DRPIV) Director David Joy, J.D. 301-796-2242 WO 51/Rm. 6254 Division of Information Disclosure Policy (DIDP) Director Nancy Sager 301-796-3491 WO 51/Rm. 6264 Deputy Director Howard Philips, J.D. 301-796-3483 Hillandale/Rm.3172

Proactive Disclosure Branch (PDB) Branch Chief Carol Doyle 301-796-3492 Hillandale/Rm.3152

Freedom of Information Branch (FOIB) Branch Chief Sudarshini (Darshini) Satchi, J.D. 301-796-3496 Hillandale/Rm.3130

OFFICE OF EXECUTIVE PROGRAMS (OEP)

DIRECTOR Mary Beth Clarke 301-796-2859 WO 51/Rm. 6144

Deputy Director Heather Brown 301-796-4304 WO51/Rm. 6156

Executive Assistant Cheryl Giganti 240-402-8294 WO 51/Rm. 6145 Ombudsman Virginia Behr 301-796-3436 WO 51/Rm. 6158 Senior Management Officer Christopher Carlsen 301-796-7629 WO 51/Rm. 6110 Product Jurisdictional Officer Cherryn Chang 301-796-2454 WO 51/Rm. 6155

Lead Administrative Officer

Stephanie Donovan 301-796-2860 WO 51/Rm. 6114

Division of Learning and Organizational Development (DLOD) Director Valerie Ostach-Fagan (Acting) 240-402-4982 WO 51/Rm. 2374 Deputy Director Valerie Ostach-Fagan 240-402-4982 WO 51/Rm. 2374

Scientific and Regulatory Education Branch (SREB) Branch Chief Shefali Doshi 301-796-1780 WO 51/Rm. 2320 Training Design and Delivery Branch (TDDB) Branch Chief Valerie Ostach-Fagan 240-402-4982 WO 51/Rm. 2374 Leadership and Organizational Development Branch (LODB) Branch Chief Valerie Ostach-Fagan 240-402-4982 WO 51/Rm. 2374

Division of Executive Operations (DEO) Director

Johanna McLatchy (Acting) 301-796-3788 WO 51/Rm. 6180 Deputy Director Vacant

Division of Advisory Committee and Consultant Management (DACCM)

Director Jayne Peterson 301-796- 9024 WO 51/Rm. 2422 Deputy Director Cicely Reese 301-796-9025 WO 31/Rm. 2420

OFFICE OF MANAGEMENT (OM)

DIRECTOR Edwin Echegoyen, M.B.A. (Acting) 301-796-3300 WO 51//Rm. 5132 Executive Assistant Edgar Ovando-Sidotti (Acting) 301-796-3300 WO 51//Rm. 5137

Deputy Director Kevin Laser (Acting) 301-796-3300 WO 51//Rm. 5132

Special Project and Initiative Staff (SPIS) Director

Edwin Echegoyen (Acting) 301-796-3300 WO 51/Rm. 5134 Ethics Liaison Staff (ELS) Director Patricia Reilly 301-796-7818 WO 51/Rm. 5158 Policies and Procedures Team Team Lead John Friel 301-796-3173 WO 51/Rm. 5116 Administrative Team Supervisory Administrative Officer Tracy Bellamy-Anderson 240-402-4140 WO 51/Rm. 5128

Division of Budget Execution and Resource Management (DBERM) Director David Caines (Acting) 240-402-0555 WO 51/Rm. 1264

Deputy Director Rixie Scott 301-796-4405 WO 51/Rm. 1260 Budget Execution Branch (BEB) Branch Chief Elizabeth Wyatt (Acting) 301-796-2136 WO 51/Rm. 1276

Financial Accountability Branch (FAB)

Branch Chief Don Kim 301-796-4407 WO 51/Rm. 1256

Acquisitions Support Branch (ASB) Branch Chief

Beth Goldberg 240-402-5101 WO 51/Rm. 1272 Division of Management Services (DMS) Director Mary Milline 301-796-4428 WO 51/Rm. 1348

Associate Director for Human Capital Jacquita Johnson-House 301-796-4148 WO 51/Rm. 1352

Associate Director for Logistics Management Angela Harris 301-796-4450 WO 51/Rm. 1344 Human Capital Management Branch (HCMB)

Branch Chief Cheryl Parker (Acting) 240-402-4323 WO 51/Rm. 1358

Human Capital Programs Branch (HCPB) Branch Chief

Zina Freeman 240-402-0038 WO 51/Rm. 1316

Facilities Operations Branch (FOB) Branch Chief

Thomas Giganti 240-276-9487 WO 51/Rm. 1370

Property and Travel Services Branch (PTSB) Branch Chief Debora Breeden 301-796-4460 WO 51/Rm. 1228

Leave and Performance Management Branch (LPMB) Branch Chief

Regina Shumate (Acting) 301-796-5364 WO 51/Rm. 1330 Division of User Fee Management and Budget Formulation (DUFMBF) Director Donal Parks 301-796-3848 Hillandale/Rm.2107 Deputy Director Lisa Berry 301-796-7225 Hillandale/Rm.2174 Generics Branch (GB)

Branch Chief Gisa Perez 301-796-4178 Hillandale/Rm.2106 Policy and Operations Branch (POB)

Branch Chief Sehree Mickel 240-402-5075 Hillandale/Rm.2114

Brands Branch (BB) Branch Chief

Jeen Min 240-402-8719 Hillandale/Rm.2152

OFFICE OF COMMUNICATIONS (OCOMM) DIRECTOR Christine Shreeve 301-796-3818 Hillandale/Rm.1126

Deputy Director Kimberly Rawlings 301-796-3818 Hillandale/Rm.1146 Associate Director for Research and Risk Communications Paula Rausch, Ph.D., R.N. 301-796-3121 Hillandale/Rm.1144 Executive Assistants Joyce Harrell 301-796-3700 Hillandale/Rm.1127 Senior Management Officer Linda Tran 301-796-3636 Hillandale/Rm.1136

Division of Online Communications (DOC) Director Paul Buckman, M.S. 301-796-3135 Hillandale/Rm.1106

Deputy Director Sally Winthrop, M.L.S. 301-796-3135 Hillandale/Rm.1122

Division of Health Communications (DHC) Director Lauren Shaham 301-796-3518 Hillandale/Rm.4110

Deputy Director Vacant

Division of Drug Information (DDI) Director Mary Kremzner, Pharm.D., M.P.H. 301-796-3144 Hillandale/Rm.4150

Deputy Director Catherine Chew, Pharm.D. 301-796-3166 Hillandale/Rm.4130

OFFICE OF COMPLIANCE (OC) DIRECTOR Donald D. Ashley, J.D. 301-796-3100 WO 51/Rm. 5270

Deputy Director Ilisa Bernstein, Pharm.D., J.D. 301-796-4723 WO 51/Rm. 5266 Deputy Director

Mike Levy, J.D. 301-796-3314 WO 51/Rm. 5276 Special Assistants Sarah Barkow (Acting) 301-796-0318 WO 51/Rm. 5272 Eunah Kostal, MBA 301-796-7435 WO 51/Rm. 5260 Executive Assistant Nyala Johnson 240-402-0068 WO 51/Rm. 5269 Senior Advisor for Special Projects Allen Lou 301-796-5652 `WO 51/Rm. 5272

Senior Regulatory Advisor Vacant Regulatory Counsel Davina R. Marano 240-402-0053 WO 51/Rm. 5263

Senior Medical Advisor John Troiani, M.D., Ph.D. 301-796-4258 WO 51/Rm. 5281

Advisor for Communications Sarah Clark-Lynn (Acting) 301-796-9110 WO 51/Rm. 5263

Program Management and Analysis Staff (PMAS) Director Collin Figueroa 301-796-5802 WO 51/Rm. 5250

Office of Manufacturing Quality (OMQ) Director

Francis Godwin (Acting) 301-796-5362 WO 51/Rm. 4352 Deputy Director for Management and Operations Kennerly K. Chapman 301-796-3271 WO 51/Rm. 4346

Deputy Director for Science and Regulatory Policy Richard L. Friedman 301-796-3268 WO 51/Rm. 4348

Senior Advisor for Regulatory Science Vacant

Associate Director for Quality Assurance Vacant Special Assistant Ellen Kempler 301-796-3753 WO 51/Rm. 4337

Manufacturing Quality Guidance and Policy Staff (MGPS) Director Paula R. Katz, J.D. 301-796-6972 WO 51/Rm. 4330 Division of Drug Quality I (DDQI)

Director Carmelo Rosa 301-796-3667 WO 51/Rm. 4354

Global Compliance Branch I (GCBI) Branch Chief Ian Deveau 301-796-5061 WO 51/Rm. 4366

Global Compliance Branch II (GCBII) Branch Chief Maan Abduldayem 301-796-3916 WO 51/Rm. 4360

Division of Drug Quality II (DDQII) Director Milind Ganjawala 301-796-3318 WO 51/Rm. 4322

Global Compliance Branch III (GCBIII) Branch Chief Milind Ganjawala 301-796-3318 WO 51/Rm. 4352

Global Compliance Branch IV (GCBIV) Branch Chief Tamara Felton-Clark 301-796-4162 WO 51/Rm. 4362

Office of Unapproved Drugs and Labeling Compliance (OUDLC)

Director Carolyn Becker, J.D. 301-796-8801 WO 51/Rm. 5188 Deputy Director Kathleen Anderson, Pharm.D. 301-796-3309 WO 51/Rm. 5182

Senior Advisor for Market Surveillance and Data Analysis Meghan Murphy, Ph.D. 301-796-3307 WO 51/Rm. 5178

Senior Advisor for Policy Sara Rothman, M.P.H. 301-796-3536 WO 51/Rm. 5197 Senior Advisor for Regulatory Sciences Huascar Batista, M.P.H. 301-796-3411 WO 51/Rm. 5164 Senior Medical Advisor Arthur Simone, M.D. 301-796-1294 WO 51/Rm. 5186

Division of Prescription Drugs (DPD) Director Gail Bormel, R.Ph., J.D. 301-796-3263 WO 51/Rm. 5184

Prescription Drugs Branch (PDB) Branch Chief James Flahive, J.D. 301-796-9293 WO 51/Rm. 5180

Compounding and Pharmacy Practices Branch (CPPB)

Branch Chief Edisa Gozun 301-796-1068 WO 51/Rm. 5196

Division of Non-Prescription Drugs and Health Fraud (DNPDHF) Director John (Brad) Pace, J.D. 301-796-3538 WO 51/Rm. 5174

Over-the-Counter Drugs Branch (OTCDB)

Branch Chief Tina Smith 301-796-2249 WO 51/Rm. 5178

Health Fraud Branch (HFB) Branch Chief Cynthia Ng (Acting) 301-196-7512 WO 51/Rm. 5109

Office of Drug Security, Integrity and Response (ODSIR) Director Thomas (T.J.) Christl 301-796-2057 WO 51/Rm. 4274 Deputy Director Meredith Francis, J.D. 301-796-3476 WO 51/Rm. 4266 Senior Advisor for Policy Connie Jung, R.Ph., Ph.D. 301-796-4712 WO 51/Rm. 4268

Division of Import Exports and Recalls (DIER) Director Carole Jones 301-796-3194 WO 66/Rm. 3654

Recalls and Shortages Branch (RSB) Branch Chief

Melissa Mannion (Acting) 301-796-3285 WO 51/Rm. 4252 Import Exports Compliance Branch (IECB)

Branch Chief Andrei Perlloni 301-796-8258 WO 51/Rm. 4278

Division of Supply Chain Integrity (DSCI) Director Eleni Anagnostiadis, R.Ph. 301-796-7606 WO 51/Rm. 4272

Supply Chain Strategy and Policy Branch (SCSPB) Branch Chief Tia M. Harper-Velazquez,Pharm.D.,J.D.301-796-3301 WO 51/Rm. 4262

Supply Chain Response and Enforcement Branch (SCREB) Branch Chief Sangeeta Vaswani Chatterjee 301-796-9256 WO 51/Rm. 4288

Office of Program and Regulatory Operations (OPRO) Director Maria Rossana (Rosemary) Cook, MBA 301-348-3968 WO 51/Rm. 5278

Deputy Director Yuexia Li, PhD 301-796-2155 WO 51/Rm. 5282 Special Assistant Amina Gilyard, MEd 240-402-5514 WO 51/Rm. 5283

Project Management and Coordination Staff I (PMSCI) Director

Carlene (Cai) Randolph, MS, MBA, PhD 240-402-8761 WO 51/Rm. 5286

Project Management and Coordination Staff II (PMSCII) Director

Melissa Hulett, MBA 301-796-4897 WO 51/Rm. 5254

Drug Registration and Listing Staff (DRLS) Director Paul Loebach 301-796-2173 WO 51/Rm. 2262

Office of Scientific Investigations (OSI) Director David Burrow, Pharm.D., J.D. (Acting) 301-796-5632 WO 51/Rm. 5348 Deputy Director David Burrow, Pharm.D., J.D. 301-796-5632 WO 51/Rm. 5348 Special Assistant Kavita C. Dada, Pharm.D. 301-796-6954 WO 51/Rm. 5358

Associate Director for Regulatory Affairs Kavita C. Dada, Pharm.D. (Acting) 301-796-6954 WO 51/Rm. 5358 Senior Advisor for Policy Mathew T. Thomas, M.D. 301-796-8684 WO 51/Rm. 5342

Policy Staff (PS)

Director Emily Gebbia, J.D. 240-402-0980 WO 51/Rm. 5262

Division of Enforcement and Postmarketing Safety (DEPS)

Director Sherry Bous, Pharm.D. 240-402-8176 WO 51/Rm. 5364

Compliance Enforcement Branch (CEB) Branch Chief Adam Donat 301-796-5316 WO 51/Rm. 5352

Postmarketing Safety Branch (PSB) Branch Chief LaShanda Long, M.S. 301-796-5465 WO 51/Rm. 5356

Division of Clinical Compliance Evaluation (DCCE)

Director Ni Aye Khin, M.D. 301-796-0911 WO 51/Rm. 5334

Good Clinical Practice Compliance Oversight Branch (GCPCOB) Branch Chief Constance Cullity, M.D., M.P.H. 301-796-3397 WO 51/Rm. 5354

Good Clinical Practice Assessment Branch (GCPAB) Branch Chief Kassa Ayalew, M.D., M.P.H. 301-796-0670 WO 51/Rm. 5370

OFFICE OF MEDICAL POLICY (OMP) DIRECTOR Jaqueline Corrigan-Curay, J.D., M.D. 301-796-2500 WO 51/Rm. 6338

Assistant Chris Plummer 301-796-0965 WO 51/Rm. 6337 Deputy Director Mohammed ElZarrad 301-796-8613 WO 51/Rm. 6342

Associate Director for Clinical Methodology Leonard Sacks, M.D. 301-796-8502 WO 51/Rm. 6326 Associate Director for Regulatory Affairs Dianne Paraoan 301-796-3161 WO 51/Rm. 3326

Senior Management Officer Debbie Begosh 301-796-1588 WO 51/Rm. 6334

Office of Prescription Drug Promotion (OPDP) Director Thomas W. Abrams, R.Ph., M.B.A. 301-796-1200 WO 51/Rm. 3314 Deputy Director CAPT Mark Askine 301-796-1200 WO 51/Rm. 3264

Division of Advertising and Promotion Review II (DAPRII) Director

Robert Dean 301-796-2215 WO 51/Rm. 3274

Deputy Director Twyla Thompson 301-796-4294 WO 51/Rm. 3282

Division of Advertising and Promotion Review I (DAPRI) Director CAPT Andrew Haffer 301-796-1200 WO 51/Rm. 3272

Deputy Director CAPT Lisa Hubbard 301-796-1200 WO 51/Rm. 3270

Office of Medial Policy Initiatives (OMPI) Director CAPT Philip Budashewitz 301-796-0577 WO 51/Rm. 6320

Deputy Director Vacant

Associate Director for Regulatory Affairs Vacant

Division of Medical Policy Development (DMPD) Director LCDR Jessica Cleck-Derenick 301-796-0390 WO 51/Rm. 6352

Deputy Director Vacant Division of Medical Policy Programs (DMPP) Director Bryson Pearsall 301-796-9617 WO 51/Rm. 6326

Deputy Director CDR Jonas Santiago 301-796-5346 WO 51/Rm. 6348 Division of Clinical Trial Quality (DCTQ) Director Alyson Karesh, M.D. 301-796-3824 WO 51/Rm. 6356 Deputy Director Kaveeta Vasisht, M.D. (Acting) 301-796-2920 WO 51/Rm. 3332

OFFICE OF TRANSLATIONAL SCIENCES (OTS)

DIRECTOR ShaAvhree Buckman-Garner, M.D., Ph.D., F.A.A.P. 301-796-2600 WO 21/Rm. 4554

Deputy Director

Mitra Ahadpour, M.D., D.A.B.A.M. 301-796-8469 WO 21/Rm. 4546 Deputy Director for Science

Juan Ruiz, Ph.D., M.B.A. 301-796-0950 WO 21/Rm. 2630 Program Support Specialist Samantha Stiles 301-796-4791 WO 21/Rm. 4545 Director, Program Management & Analysis Staff (PMAS) Raya S. McCree 301-796-1708 WO 21/Rm. 4512

Associate Director for Regulatory Affairs Vacant

OFFICE OF BIOSTATISTICS (OB)

Director Aloka Chakravarty, Ph.D. (Acting) 301-796-1655 WO 21/Rm. 3550

Deputy Director Dionne Price, Ph.D. (Acting) 301-796-1274 WO 21/Rm. 3508

Associate Director Sue Jane Wang, Ph.D. 301-796-0831 WO 21/Rm. 3506

Associate Director for Statistical Science & Policy Thomas Permutt, Ph.D. 301-796-1271 WO 21/Rm. 3614 Associate Director for Biosimilar Review Shein-Chung Chow, Ph.D. 301-796-8712 WO 21/Rm. 3548 Supervisory Administrative Officer Vonda Jewell 301-796-8371 WO 21/Rm. 4506

Administrative Support Assistant Tenika Casey 301-348-1862 WO 21/Rm. 3547

Division of Biometrics I (DBI) Director Hsien-Ming J. Hung, Ph.D. 301-796-1092 WO 21/Rm. 4616

Deputy Director Sue Jane Wang, Ph.D. (Acting) 301-796-0831 WO 21/Rm. 3506

Division of Biometrics II (DBII)

Director Mark Rothmann, Ph.D. (Acting) 301-796-1743 WO 21/Rm. 3616

Deputy Director Gregory Levin (Acting) 301-796-4428 WO 21/Rm. 3612

Division of Biometrics III (DBIII)

Director Laura Lee Johnson, Ph.D. (Acting) 240-402-6142 WO 21/Rm. 3668

Deputy Director Jingyu (Julia) Luan, Ph.D. 301-796-2148 WO 21/Rm. 3626

Division of Biometrics IV (DBIV)

Director Daphne Ty Lin, Ph.D. 301-796-0751 WO 21/Rm. 3604

Deputy Director Daphne Ty Lin, Ph.D. 301-796-0751 WO 21Rm. 3604

Division of Biometrics V (DBV) Director Rajeshwari Sridhara, Ph.D. 301-796-1759 WO 21/Rm. 3512

Deputy Director Thomas Gwise, Ph.D. 301-796-6034 WO 21/Rm. 3546

Division of Biometrics VI (DBVI)

Director Yi Tsong, Ph.D. 301-796-1013 WO 21/Rm. 4630 Deputy Director

Atiar Mohammad Rahman, Ph.D. 301-796-0979 WO 21/Rm. 4657

Division of Biometrics VII (DBVII) Director Mark Levenson, Ph.D. 301-796-2097 WO 21/Rm. 4626 Deputy Director Mat Soukup, Ph.D. 301-796-1005 WO 21/Rm. 4658 Division of Biometrics VIII (DBVIII) Director Stella Grosser, Ph.D. 240-402-3868 WO 21/Rm. 4628 Deputy Director Fairouz Makhlouf, Ph.D. 240-402-3869 WO 21/Rm. 4608 OFFICE OF CLINICAL PHARMACOLOGY (OCP)

Director Issam Zineh, Pharm.D.,M.P.H.,F.C.P.,F.C.C.P. 301-796-4756 WO 51/Rm. 3178

Program Support Specialist Karen Graves 301-796-5008 WO 51/Rm. 3177

Deputy Director Shiew-Mei Huang, Ph.D. 301-796-1541 WO 51/Rm. 3188

Associate Director of Genomics

Michael Pacanowski, Pharm.D., M.P.H. 301-796-3919 WO 51/Rm. 2132

Supervisory Administrative Officer Zachary Mitchell 240-402-3194 WO 21/Rm. 4544

Division of Clinical Pharmacology I (DCPI) Director

Mehul Mehta, Ph.D. 301-796-1573 WO 51/Rm. 2178 Deputy Director Ramana S. Uppoor, Ph.D. 301-796-1619 WO 51/Rm. 2182

Division of Clinical Pharmacology II (DCPII) Director Chandrahas Sahajwalla, Ph.D. 301-796-1599 WO 51/Rm. 3142

Deputy Director Suresh Doddapaneni, Ph.D. 301-796-1526 WO 51/Rm. 3136

Division of Clinical Pharmacology III (DCPIII) Director Shiew-Mei Huang, Ph.D. (Acting) 301-796-1541 WO 51/Rm. 3188

Deputy Director Vacant

Division of Clinical Pharmacology IV (DCPIV) Director John A. Lazor, Pharm.D. 301-796-1559 WO 51/Rm. 2134

Deputy Director Kellie Reynolds, Ph.D. 301-796-1594 WO 51/Rm. 2108

Division of Clinical Pharmacology V (DCPV) Director Nam Atiqur Rahman, Ph.D. 301-796-1591 WO 51/Rm. 2188

Deputy Director Brian Booth, Ph.D. 301-796-1508 WO 51/Rm. 2186

Division of Pharmacometrics (DPM) Director Yaning Wang, Ph.D. 301-796-1624 WO 51/Rm. 2106

Deputy Director Vacant

Division of Applied Regulatory Science (DARS) Director David Strauss, M.D., Ph.D. 301-796-6323 WO 64/Rm. 2072

Deputy Director Vikram Patel, Ph.D. 301-796-0121 WO 64/Rm. 2026

Office of Computational Science (OCS) Director Lilliam Rosario, Ph.D. 301-796-8501 WO 21/Rm. 1510 Deputy Director Vacant

Office of Study Integrity and Surveillance (OSIS) Director Sean Kassim, Ph.D. 301-796-3865 WO 22/Rm. 1442

Deputy Director Sally Choe, Ph.D. 301-796-7960 WO 22/Rm. 1440

Division of New Drug Bioequivalence Evaluation (DNDBE) Director Charles Bonapace, Ph.D. (Acting) 301-796-1507 WO 51/Rm. 5228

Deputy Director Arindam Dasgupta 301-796-3326 WO 51/Rm. 5226

Division of Generic Drug Bioequivalence Evaluation (DGDBE) Director Seongeun (Julia) Cho, Ph.D. 301-796-5032 WO 22/Rm. 1438

Deputy Director John Kadavil (Acting) 240-402-6643 WO 51/Rm. 5372

OFFICE OF SURVEILLANCE AND EPIDEMIOLOGY (OSE)

DIRECTOR Gerald Dal Pan, M.D., M.H.S. 301-796-2380 WO 22/Rm. 4304

Executive Assistant Barbara M. McCary 301-796-2000 WO 22/Rm. 4303

Deputy Director Robert “Bob” Ball, M.D., M.P.H. 240-402-0397 WO 22/Rm. 4300 Associate Director for Public Health Initiatives Judy Staffa, Ph.D. 301-796-2380 WO 22/Rm. 2404 Regulatory Science Staff (RSS) Staff Director Amarilys Vega, M.D. 301-796-2380 WO22/Rm. 4312

Regulatory Affairs Staff (RAS) Staff Director Maureen Melvin, M.S. 301-796-2380 WO22/Rm. 4480

Program Management & Analysis Staff (PMAS) Director Amy Garvin 301-796-3413 WO22/Rm. 4326

Project Management Staff (PMS) Director

Jill Bourdage, R.Ph. 301-796-2380 WO 22/Rm. 4478

Office of Medication Error Prevention and Risk Management (OMEPRM) Director Claudia Manzo, Pharm.D. 301-796-0182 WO 22/Rm. 2418

Deputy Director Lubna Merchant, Pharm.D. (Acting) 301-796-5162 WO 22/Rm. 4408

Division of Medication Errors Prevention and Analysis (DMEPA)

Director Todd Bridges 301-796-2360 WO 22/Rm. 4416

Deputy Director CDR Irene Chan, Pharm.D. 301-796-2360 WO 22/Rm. 4420

Division of Risk Management (DRISK) Director Cynthia LaCivita, Pharm.D. 301-796-0307 WO 22/Rm. 2424

Deputy Director Jamie Wilkins-Parker 301-796-6113 WO 22/Rm. 2428

Office of Pharmacovigilance & Epidemiology (OPE)

Director Judith Zander, M.D. 301-796-2350 WO 22/Rm. 3474

Deputy Director Michael Blum, M.D. 301-796-2350 WO 22/Rm. 3478

Division of Epidemiology I (DEPI) Director Simone Pinheiro 301-796-2370 WO 22/Rm. 2472

Deputy Director CDR Sukminder Sandhu 301-796-0162 WO 22/Rm. 2470 Division of Epidemiology II (DEPII) Director CDR David Money, R.Ph., M.P.H. 301-796-0507 WO 22/Rm. 2474

Deputy Director Lockwood Taylor, Ph.D., M.P.H. 240-420-5229 WO 22/Rm. 2406 Deputy Director for Drug Use LCDR Grace Chai, Pharm.D. 301-796-5116 WO 22/Rm. 2464

Division of Pharmacovigilance I (DPVI)

Director Cynthia Kortepeter, Pharm.D. 301-796-1110 WO 22/Rm. 3418

Deputy Director LCDR Monica Muñoz, Ph.D., M.S. 301-796-3698 WO 22/Rm. 3400

Division of Pharmacovigilance II (DPVII) Director CDR S. Chris Jones, Pharm.D. 301-796-1463 WO 22/Rm. 3464 Deputy Director CDR Ida-Lina Diak, Pharm.D. 301-796-1986 WO 22/Rm. 3412

OFFICE OF STRATEGIC PROGRAMS (OSP)

DIRECTOR Theresa Mullin, Ph.D. 301-796-3800 WO 51/Rm. 1178

Deputy Director Mary Ann Slack 301-796-0603 WO 51/Rm. 1188

Executive Assistant Angela Kwon 301-796-4957 WO51/Rm. 1175 Administrative Management Team Senior Management Officer

Christine Daley 301-796-5249 WO 51/Rm. 1184 Lead Management Officer Kim Bibbs 301-796-1998 WO 22/Rm. 1104

Office of Program & Strategic Analysis (OPSA)

Director Andrew Kish 301-796-5215 WO51/Rm. 1142 Deputy Director Adam Kroetsch 301-796-3842 WO51/Rm. 1168

Program Evaluation & Implementation Staff (PEIS) Director Kim Taylor (Acting) 240-402-5193 WO 51/Rm. 1152

Economics Staff (ES) Director Andreas Schick 301-796-8741 WO 51/Rm. 1186

Performance Analysis and Data Services Staff (PADSS) Director Reza Kasemi-Tabriz 301-796-3686 WO 51/Rm. 1182

Lean Management Staff (LMS) Director Michael Rappel (Acting) 301-796-37260 WO 51/Rm. 1128

Office of Business Informatics (OBI) Director Hilmar Hamann, Ph.D. 301-796-0375 WO 22/Rm. 1124

Deputy Director Gregory Chin 240-402-0388 WO 22/Rm. 1102

Division of Regulatory Review and Drug Safety Services and Solutions (DRRDSSS) Director Jonathan Rappaport 301-796-2893 WO 22/Rm. 1110

Division of Business Management Services and Solutions (DBMSS) Director Atash Mehta 240-402-4190 WO 22/Rm. 1114

Division of Data Management Services and Solutions (DDMSS) Director Vacant Division of Drug Quality and Compliance Services and Solutions (DDQCSS)

Director Vacant

Innovation Management and Architecture Services & Solutions (IMASS) Technical Architect Chao (Ethan) Chen 301-796-7626 WO 22/Rm. 6130

OFFICE OF NEW DRUGS (OND) DIRECTOR Janet Woodcock, M.D. (Acting) 301-796-0700 WO 22/Rm. 6304 Executive Assistant Victor Vail 301-796-3169 WO 22/Rm. 6305 Deputy Director Peter Stein, M.D. 301-796-0189 WO 22/Rm. 6306

Deputy Director Patrick Frey 301-796-3844 WO 22/RM. 6310

Pharmacology / Toxicology Staff (PTS) Associate Director Karen L. Davis Bruno, Ph.D. 301-796-1199 WO 22/Rm. 6428 Regulatory Affairs Team (RAT) Associate Director Patrick Frey (Acting) 301-796-3844 WO 22/Rm. 6310 Learning and Career Development Team (LCDT)

Associate Director Susanne Walker 301-796-5229 WO 22/Rm. 6486

Guidance and Policy Team (GPT)

Associate Director Sally Loewke, M.D. 301-796-0700 WO 22/Rm. 6424 Safety Policy and Research Team (SPRT)

Associate Director Mwango Kashoki, M.D. 301-796-1238 WO 22/Rm. 6310

Labeling Development Team Associate Director

Eric Brodsky, M.D. 301-796-0855 WO 22/Rm. 6485 Clinical Outcomes Assessment Team Associate Director

Elektra Papadopoulos, M.D. 301-796-0967 WO 22/Rm. 6429

Rare Diseases Program (RDP) Associate Director

Jonathan Goldsmith, M.D. 240-402-9959 WO 22/Rm. 6480

Therapeutic Biologics and Biosimilars Team (TBBT) Associate Director

Leah Christl, Ph.D. 301-796-0868 WO 22/Rm. 6426 Associate Director Joseph Franklin, Ph.D.,J.D. 301-796-8583 WO 22/Rm. 6300

Program Management & Analysis Staff (PMAS) Senior Management Officer

Peter Kelchner (Acting) 301-796-7138 WO 22/Rm. 6371 Biomedical Informatics and Regulatory Review Science (MIRRS) Vaishali Popat, M.D., M.P.H. 301-796-3915 WO 22/Rm. 5324 Biomarker Development and Regulatory Science Team (BDRST) Christopher Leptak, M.D., Ph.D. 301-796-0017 WO 22/Rm. 6462

OFFICE OF DRUG EVALUATION I (ODEI) Director Ellis Unger, M.D. 301-796-1157 WO 22/Rm. 4208 Deputy Director Robert Temple, M.D. (Acting) 301-796-2270 WO 22/Rm. 4208 Associate Director for Regulatory Affairs Colleen LoCicero 301-796-2270 WO 22/Rm. 4216 Lead Administrative Officer Donna Wade 301-796-4910 WO 22/Rm. 4204

Division of Cardiovascular and Renal Products (DCRP)

Director Norman Stockbridge, M.D. Ph.D. 301-796-2240 WO 22/Rm. 4168 Deputy Director Stephen Grant, M.D. 301-796-2277 WO 22/Rm. 4170

Deputy Director for Safety Mary Ross Southworth, M.D. 301-796-0539 WO 22/Rm. 4238

Supervisory Project Manager Edward Fromm 301-796-2240 WO 22/Rm. 4162

Division of Neurology Products (DNP) Director William Dunn, M.D. 301-796-2250 WO 22/Rm. 4338 Deputy Director Eric Bastings, M.D. 301-796-2250 WO 22/Rm. 4338 Deputy Director for Safety Alice Hughes 301-796-1091 WO 22/Rm. 4232

Supervisory Project Manager Jacqueline Ware, R.Ph. 301-769-2250 WO 22/Rm. 4346 Lois Freed, M.D. 301-796-1070 WO 22/Rm. 4370

Division of Psychiatry Products (DPP)

Director Mitchell Mathis, M.D. 301-796-1705 WO 22/Rm. 4112 Deputy Director

Tiffany Farchione, M.D. 301-796-7638 WO 22/Rm. 4110 Deputy Director for Safety Marc Stone, M.D. 301-796-1149 WO 22/Rm. 4122

Supervisory Project Managers Steven Hardeman, R.Ph. 301-796-1081 WO 22/Rm. 4390 Paul David, R.Ph. 301-796-2260 WO 22/Rm. 4100

OFFICE OF DRUG EVALUATION II (ODEII) Director Curtis Rosebraugh, M.D., M.P.H. 301-796-2310 WO 22/Rm. 3214 Deputy Director

Mary Thanh Hai, M.D. 301-796-2310 WO 22/Rm. 3210

Regulatory Information Specialist Velma Cunningham 301-796-1197 WO 22/Rm. 3221 Project Specialist

Misbah Baig 301-796-1169 WO 22/Rm. 3217 Associate Director for Regulatory Affairs Sara Stradley 301-796-1298 WO 22/Rm. 3206 Associate Director for Regulatory Science Silvana Borges, M.D. 301-796-0963 WO 22/Rm. 3200 Lead Management Officer Thomas Cunningham 301-796-1196 WO 22/Rm. 3218

Division of Metabolism and Endocrinology Products (DMEP) Director Mary Thanh-Hai, M.D. 301-796-2310 WO 22/Rm. 3210

Deputy Director James Smith, M.D. 301-796-1317 WO 22/Rm. 3372 Deputy Director for Safety Jennifer Pippins, M.D. 301-796-5067 WO 22/Rm. 3319

Chief, Project Management Staff Julie Van der Waag, M.P.H. 301-796-1280 WO 22/Rm. 3350 Pamela Lucarelli 301-796-3961 WO 22/Rm. 3364

Administrative Officer Nicole Cooper 301-796-1193 WO 22/Rm. 3218

Division of Pulmonary, Allergy and Rheumatology Products (DPARP) Director

Badrul Chowdhury, M.D., Ph.D. 301-796-2300 WO 22/Rm. 3326

Deputy Director Lydia Gilbert-McClain, M.D. 301-796-1215 WO 22/Rm. 3330

Deputy Director of Safety Sally Seymour, M.D. 301-796-1290 WO 22/Rm. 3208 Chief, Project Management Staff Sandra L. Barnes 301-796-1174 WO 22/Rm. 3312 Ladan Jafari 301-796-1231 WO 22/Rm. 3320

Administrative Officer Stanley Allen 301-796-1169 WO 22/Rm. 3223

Division of Anesthetics, Analgesia and Addiction Products (DAAAP) Director Sharon Hertz, M.D. 301-796-2280 WO 22/Rm. 3156

Deputy Director Rigoberto Roca, M.D. 301-796-2280 WO 22/Rm. 3152 Deputy Director Ellen Fields, M.D. 301-796-2280 WO 22/Rm. 3160

Deputy Director for Safety Judith Racoosin, M.D., M.P.H. 301-796-2280 WO 22/Rm. 3158 Chief, Project Management Staff Parinda Jani 301-796-1232 WO 22/Rm. 3166 Matthew Sullivan 301-796-1245 WO 22/Rm. 3168

Administrative Officer Keisha Charles 240-402-9034 WO 22/Rm. 3223

OFFICE OF DRUG EVALUATION III (ODEIII) Director Julie Beitz, M.D. 301-796-0848 WO 22/Rm. 5214

Deputy Director Victor Crentsil 301-796-1047 WO 22/Rm. 5344

Associate Director for Regulatory Affairs Richard (Wes) Ishihara 301-796-0069 WO 22/Rm. 5208

Regulatory Scientist Julieann DeBeau 301-796-0883 WO 22/Rm. 5206

Management Officer Antoinette Mason 301-796-0954 WO 22/Rm. 5218

Lead Administrative Officer Vacant

Division of Gastroenterology and Inborn Errors Products (DGIEP) Director Donna Griebel, M.D. 301-796-2120 WO 22/Rm. 5110

Deputy Director Dragos Roman, M.D. 301-796-1285 WO 22/Rm. 5152

Deputy Director for Safety Joyce Korvick, M.D. 301-796-2120 WO 22/Rm. 5102 Supervisory Project Manager

Brian Strongin 301-796-2120 WO 22/Rm. 5116 Division of Bone Reproductive & Urologic Products (DBRUP) Director

Hylton Joffe, M.D. 301-796-1954 WO 22/Rm. 5384

Administrative Officer Deborah Ivey 240-402-5986 WO 22/Rm. 5220 Deputy Director

Audrey Gassman, M.D. 301-796-0897 WO 22/Rm. 5386

Deputy Director for Safety Christine Nguyen, M.D. 301-796-0960 WO 22/Rm. 5330

Safety Regulatory Health Project Manager Meredith Hillig 301-796-1218 WO 22/Rm. 5333

Supervisory Project Managers Margaret Kober 301-796-0934 WO 22/Rm. 5376

Jennifer Mercier 301-796-0957 WO 22/Rm. 5390 Administrative Officer Fustina Lambert (Acting) 240-402-5234 WO 22/Rm. 5520

Division of Dermatology and Dental Products (DDDP)

Director Kendall Marcus, M.D. 301-796-0755 WO 22/Rm. 5202 Deputy Director Jill Lindstrom, M.D. 301-796-0944 WO 22/Rm. 5204 Deputy Director for Safety Tatiana Oussova 301-796-1267 WO 22/Rm. 5164 Supervisory Project Manager Barbara Jean Gould 301-796-4224 WO 22/Rm. 5166

OFFICE OF DRUG EVALUATION IV (ODEIV) Director Charles J. Ganley, M.D. 301-796-0895 WO 22/Rm. 5306

Deputy Director Lesley-Anne Furlong, M.D. 301-796-0892 WO 22/Rm. 5300 Associate Director Susan Johnson, Pharm.D., Ph.D. 301-796-0925 WO 22/Rm. 5309

Project Specialist Fa-ry Grant 240-402-2115 WO 22/Rm. 5301

Associate Director for Regulatory Affairs Jagjit Grewal 301-796-0846 WO 22/Rm. 5305

Associate Director for Regulator Science Jian Wang, Ph.D. 301-796-3846 WO22/Rm. 5309 Associate Director for Informatics

Gary Gensinger 301-796-0589 WO22/Rm. 5307 Lead Administrative Officer Merla Rae Matheny 301-796-0955 WO 22/Rm. 5304

Division of Nonprescription Drug Products (DNDP) Director

Theresa Michele, M.D. 301-796-1593 WO 22/Rm. 5484 Deputy Director Karen M. Mahoney, MD. 301-796-1250 WO 22/Rm. 5486

Deputy Director for Safety Valerie Pratt, M.D. 301-796-1050 WO 22/Rm. 5464 Administrative Support Assistant Dalmas Robinson 301-796-0974 WO 22/Rm. 5479

Administrative Officer Pamela M. Hampton 301-796-0904 WO 22/Rm. 5304 Division of Medical Imaging Products (DMIP)

Director Libero Marzella, M.D. 301-796-1414 WO 22/Rm. 5406

Deputy Director Alexander Gorovets, M.D. 301-796-0901 WO 22/Rm. 5460

Administrative Support Assistant Christina Duarte 240-402-5338 WO 22/Rm. 5429

Deputy Director of Safety Ira Krefting, M.D. 301-796-1135 WO 22/Rm. 5402

Supervisory CSO Kyong Kang 301-796-1970 WO 22/Rm. 5410

Administrative Officer Nikisha Joyner 240-402-9741 WO 22/Rm. 5304 Division of Pediatrics and Maternal Health (DPMH) Director Lynne Yao, M.D. 301-796-2141 WO 22/Rm. 6406 Deputy Director John Alexander, M.D. (Acting) 301-796-0665 WO 22/Rm. 6102 Administrative Officer Maryam Baig 301-796-5263 WO 22/Rm. 5303

OFFICE OF ANTIMICROBIAL PRODUCTS (OAP)

Director Edward M. Cox, M.D., M.P.H. 301-796-1300 WO 22/Rm. 6212

Deputy Director John J. Farley, M.D., M.P.H. 301-796-1300 WO 22/Rm. 6208

Associate Director for Regulatory Affairs Katherine Schumann 301-796-1182 WO 22/Rm. 6242 Associate Director for Medical Countermeasures Barbara Styrt, M.D., M.P.H., 301-796-1300 WO 22/Rm. 6338

Lead Administrative Officer Dana Schuhly 301-796-0806 WO 22/Rm. 6216

Division of Anti-Infective Products (DAIP) Director Sumathi Nambiar, M.D., M.P.H. 301-796-0772 WO 22/Rm. 6236

Deputy Director

Dmitri Iarikov, M.D. (Acting) 301-796-2292 WO 22/Rm. 6376

Supervisory Project Managers Camen DeBellas 301-796-1203 WO 22/Rm. 6120

Maureen Dillon-Parker 301-796-0706 WO 22/Rm. 6182

Division of Anti-Viral Products (DAVP) Director Debra B. Birnkrant, M.D. 301-796-0682 WO 22/Rm. 6332

Deputy Director

Jeffrey Murray, M.D., M.P.H. 301-796-0770 WO 22/Rm. 6370 Supervisory Project Managers

Karen Winestock 301-796-0834 WO 22/Rm. 6324 Elizabeth Thompson 301-796-0824 WO 22/Rm. 6362

Division Transplant and Ophthalmology Products (DTOP) Director Renata Albrecht, M.D. 301-796-1600 WO 22/Rm. 6164

Deputy Director Wiley A. Chambers, M.D. 301-796-0690 WO 22/Rm. 6108

Supervisory Project Manager Diana Willard 301-796-0833 WO 22/Rm. 6132

Judit Milstein 301-796-0763 WO 22/Rm. 6180

OFFICE OF HEMATOLOGY AND ONCOLOGY PRODUCTS (OHOP) Director

Richard Pazdur, M.D. 301-796-2340 WO 22/Rm. 2212 Deputy Director Gideon Blumenthal (Acting) 301-796-5369 WO 22/Rm. 2247

Regulatory Information Specialist Bertha Mejia 301-796-2131 WO 22/Rm. 2221 Lead Administrative Officer Sabrina Hunter 301-796-2821 WO 22/Rm. 2241 Management and Program Analyst Stanley Allen 301-796-1169 WO 22/Rm. 2215

Associate Director for Regulatory Affairs Tamy Kim, Pharm.D. 301-796-1125 WO 22/Rm. 2206

Associate Director for Oncology Science Greg Reaman, M.D. 301-796-0785 WO 22/Rm. 2202 Regulatory Scientist

Julie Schneider, Ph.D. 240-402-4658 WO 22/Rm. 2110

Division of Oncology Products I (DOPI) Director Julia Beaver (Acting) 240-402-0489 WO 22/Rm. 2100

Deputy Director Amna Ibrahim, M.D. 301-796-1374 WO 22/Rm. 2106

Administrative Officer Jesse Jackson 240-402-4158 WO22/Rm. 2219 Project Specialist Dolores Bowen 240-402-3198 WO22/Rm. 2125

Supervisory CSO

Christy Cottrell 301-796-4256 WO 22/Rm. 2122 Alice Kacuba 301-796-1381 WO 22/Rm. 2104

Division of Hematology Products (DHP) Director Ann T. Farrell, M.D. 301-796-7550 WO 22/Rm. 2114

Deputy Director Edvardas Kaminskas, M.D. 301-796-1383 WO 22/Rm. 2372

Administrative Officer Alexander Levillain 240-402-5646 WO 22/Rm. 2213

Supervisory CSO Theresa Carioti 301-796-2848 WO 22/Rm. 2317 Amy Baird 301-796-4969 WO 22/Rm. 2329

Division of Oncology Products II (DOPII)

Director Patricia Keegan, M.D. 301-796-1387 WO 22/Rm. 2328

Deputy Director Joseph Gootenberg, M.D. 301-796-1362 WO 22/Rm. 2324

Administrative Officer John Brown 301-796-2956 WO 22/Rm. 2215 Supervisory CSO

Melanie Pierce 301-796-1273 WO 22/Rm. 2340 Monica Hughes 301-796-9225 WO 22/Rm. 2306

Division of Hematology Oncology Toxicology Products (DHOT) Director John Leighton, Ph.D. 301-796-1398 WO 22/Rm. 2204

Deputy Director Haleh Saber 301-796-1410 WO 22/Rm. 2117 Management and Program Analyst Stanley Allen 301-796-1169 WO 22/Rm. 2215

OFFICE OF GENERIC DRUGS (OGD) DIRECTOR Kathleen (Cook) Uhl, M.D. 240-402-7920 WO 75/Rm. 1692

Deputy Director John Peters, M.D. 240-402-3876 WO 75/Rm. 1690

Administrative Support Assistant

Michelle Devlin 240-402-2521 WO 75/Rm. 1695

Clinical Safety Surveillance Staff (CSSS) Director Howard Chazin, M.D. 240-402-8271 WO 75/Rm. 1682 Program Management and Analysis Staff (PMAS) Director Carla Jones, M.S. 301-796-7072 WO 75/Rm. 1653 Communications Staff (CS) Director Jordana O’Grady, M.A. 301-796-5345 WO 75/Rm. 1694

Regulatory Affairs Team (RAT)

Supervisory Associate Director

Mary J. Dempsey 240-402-7926 WO 75/Rm. 1708

OFFICE OF RESEARCH AND STANDARDS (ORS) Director

Robert A. Lionberger, Ph.D. 240-402-7957 WO 75/Rm. 4722

Deputy Director Lei Zhang, Ph.D. 301-796-1635 WO 75/Rm. 4724

Division of Therapeutic Performance (DTP)

Director Markham Luke, M.D. 301-796-5556 WO 75/Rm. 4712

Deputy Director Xiaohui (Jeff) Jiang, Ph.D. 240-402-7964 WO 75/Rm. 4716

Division of Quantitative Methods and Modeling (DQMM)

Director Liang Zhao, Ph.D. 240-402-4468 WO 75/Rm. 4702

Deputy Director Myong-Jin Kim, Ph.D. 301-796-1553 WO 75/Rm. 4682

OFFICE OF BIOEQUIVALENCE (OB)

Director Dale Conner, Pharm.D. 240-402-3914 WO 75/Rm. 2718

Deputy Director Trueman Sharp, M.D. 301-796-8191 WO 75/Rm. 2720

Division of Bioequivalence I (DBI)

Director Bing Li, Ph.D. 240-402-3916 WO75/Rm. 2674

Deputy Director

Utpal Munshi, Ph.D. 240-402-3918 WO 75/Rm. 2682 Division of Bioequivalence II (DBII)

Director Ethan Stier, Ph.D. 240-402-3962 WO 75/Rm. 2714

Deputy Director

Xiaojian Jiang, Ph.D. 240-402-3964 WO 75/Rm. 2728

Division of Bioequivalence III (DBIII) Director

Nilufer Tampal, Ph.D. 240-402-3915 WO 75/ Rm. 2688 Deputy Director

April Braddy, Ph.D. 240-402-3917 WO 75/Rm. 2702

Division of Clinical Review

Director Sarah Yim, M.D. 301-796-1960 WO 75/Rm. 2522

Deputy Director Daiva Shetty, M.D. 240-402-3866 WO 75/Rm. 2518

OFFICE OF GENERIC DRUG POLICY (OGDP) Director Maryll Toufanian (Acting) 240-402-7944 WO 75/Rm. 1720

Deputy Director Kristin Davis, J.D. (Acting) 301-796-0418 WO 75/Rm. 1716

Division of Legal & Regulatory Support (DLRS)

Director Christopher Pruitt, J.D. 240-402-4502 WO 75/Rm. 1688

Deputy Director CAPT Martin Shimer, R.Ph. 240-402-8783 WO 75/Rm. 1678 Division of Policy Development (DPD)

Director Martha Nguyen, J.D. 301-796-3471 WO 75/Rm. 1676

Deputy Director Susan Levine, J.D. 240-402-7936 WO 75/Rm. 1674

OFFICE OF REGULATORY OPERATIONS (ORO)

Director Edward (Ted) Sherwood 301-796-1605 WO 75/Rm. 3720

Deputy Director CDR Vincent Sansone, Pharm.D. 240-402-9075 WO 75/Rm. 3722

Division of Labeling Review (DLR)

Director CAPT Chi Ann (Ruby) Wu, Pharm.D. 240-402-8831 WO 75/Rm. 3654

Deputy Director

CAPT Lillie Golson, Pharm.D. 240-402-8638 WO 75/Rm. 3662

Division of Filing Review (DFR) Director Johnny Young, M.A. 240-402-8839 WO 75/Rm. 3640

Deputy Director

Julia Lee, Ph.D. 240-402-8685 WO 75/Rm. 3646

Divison of Project Management (DPM)

Director Denise Toyer McKan, Pharm.D. 240-402-9016 WO 75/Rm. 3702

Deputy Director CAPT Aaron Sigler, Pharm.D. 240-402-8786 WO 75/Rm. 3682

Division of Quality Management Systems (DQMS)

Director Paula McKeever (Acting) 240-402-7937 WO 75/Rm. 3716 Deputy Director CAPT Steven Mazzella, M.B.A. (Acting) 240-402-8754 WO 75/Rm. 3694

OFFICE OF PHARMACEUTICAL QUALITY (OPQ)

DIRECTOR Michael Kopcha, Ph.D.,R.Ph. 301-796-5400 WO 51/Rm. 6133

Deputy Director

Lawrence Yu, Ph.D. 240-402-3116 WO 51/Rm. 4184 Associate Director for Scientific Staff Katherine Tyner (Acting) 301-796-0085 WO 51/RM. 4146

Program Management and Analysis Staff (PMAS) Director Candee Chadwick 301-796-1511 WO 51/Rm. 4188

OFFICE OF BIOTECHNOLOGY PRODUCTS (OBP) Director

Steven Kozlowski, M.D. 301-796-2390 WO 71/Rm. 2230

Deputy Director Jeffrey Baker, Ph.D. 301-796-5356 WO 71/Rm. 2236

Division of Biotechnology Review and Research I (DBRRI)

Director Kathleen Clouse-Strebel, Ph.D. 240-402-9446 WO 71/Rm. 2240

Division of Biotechnology Review and Research II (DBRRII) Director

David Frucht, M.D. 240-402-9533 WO 52-72/Rm. 2302

Division of Biotechnology Review and Research III (DBRRIII) Director

Amy Rosenberg, M.D. 240-402-9789 WO 71/Rm. 2238

Division of Biotechnology Review and Research IV (DBRRIV) Director

Gibbes Johnson, Ph.D. 240-402-9611 WO 52-72/Rm. 2218

OFFICE OF NEW DRUG PRODUCTS (ONDP) Director

Sarah Pope Miksinski, Ph.D. 301-796-1436 WO 75/Rm. 6414 Deputy Director M. Scott Furness, Ph.D. 301-796-0180 WO 75/Rm. 6510

Division of Life Cycle API (DLCAPI) Director David Skanchy, Ph.D. 240-402-8789 WO 75/Rm. 6722

Division of New Drug API (DNDAPI) Director Ali Al Hakim, Ph.D. 301-796-0202 WO 21/Rm. 2524 Division of New Drug Products I (DNDPI) Director Thomas Oliver, Ph.D. 301-796-1728 WO 21/Rm.1602

Division of New Drug Products II (DNDPII) Director Eric Duffy, Ph.D. 301-796-1666 WO 21/Rm. 2614

Division of Biopharmaceutics (DB) Director Paul Seo, Ph.D. 301-796-4874 WO 21/Rm. 1628

OFFICE OF POLICY FOR PHARMACEUTICAL QUALITY (OPPQ)

Director Ashley Boam, B.S.E., M.S.B.E. 301-796-6341 WO 51/Rm. 4192

Deputy Director Brian Hasselbalch, B.S. (Acting) 301-796-3279 WO 51/Rm. 4364

Division of Regulations, Guidance and Standards (DRGS) Director Grace McNally 301-796-3286 WO 51/Rm. 4374

Division of Internal Policies and Programs (DIPP) Director Laurie Graham, B.S., M.S. 301-796-5216 WO 51/Rm. 4234

OFFICE OF PROCESS AND FACILITIES (OPF) Director

Lawrence Yu, Ph.D. (Acting) 240-402-3116 WO 51/Rm. 4178

Deputy Director Lynne Ensor (Acting) 240-402-8627 WO 51/Rm. 2272

Division of Process Assessment I (DPAI) Director Rapti Madurawe 301-796-1408 WO 51/Rm. 2278

Division of Process Assessment II (DPAII) Director Sharmista Chatterjee 301-796-2252 WO 51/Rm. 4324

Division of Process Assessment III (DPAIII) Director Naiqi Ya 240-402-9121 WO 51/Rm. 2276

Division of Microbiology Assessment (DMA) Director Vacant

Division of Inspectional Assessment (DIA) Director LCDR Mahesh Ramanadham (Acting) 301-796-3272 WO 51/Rm. 4238

OFFICE OF SURVEILLANCE (OS) Director Lucinda Buhse, Ph.D. 240-402-4595 WO 51/Rm. 4142

Deputy Director

Lyle Canida 301-796-1242 WO 51/Rm. 4134 Division of Quality Intelligence, Risk Analysis and Modeling (DQIRAM) Director Jennifer Maguire 240-402-4817 WO 51/Rm. 2208 Division of Quality Surveillance Assessment (DQSA) Director Teddi Lopez 301-796-3255 WO 51/Rm. 3244

OFFICE OF TESTING AND RESEARCH (OTR) Director David Keire, Ph.D. (Acting) 314-539-3850 St. Louis Mo. Deputy Director Larry (Sau) Lee, Ph.D. 301-796-2905 WO 22/Rm. 2130

Division of Product Quality Research (DPQR) Director

Celia Cruz, Ph.D. 301-796-2143 WO 64/Rm. 1070

Division of Pharmaceutical Analysis (DPA) Director Jason Rodriguez (Acting) 314-539-3855 St. Louis Mo.

OFFICE OF PROGRAM AND REGULATORY OPERATIONS (OPRO) Director Giuseppe Randazzo 301-796-3277 WO 75/Rm. 4514

Deputy Director Vacant

Division of Regulatory and Business Process Management I (DRBPMI) Director Tanya Clayton (Acting) 301-796-0871 WO 75/Rm. 4506

Division of Regulatory and Business Process Management II (DRBPMII) Director Robert Gaines 240-402-4799 WO 75/Rm. 4526

Division of Operational Excellence, Learning and Professional Development (DOELPD) Director Lloyd Ballou, (Acting) 240-402-9016 WO 75/Rm. 3678

OFFICE OF LIFECYCLE DRUG PRODUCTS (OLDP)

Director Susan Rosencrance, Ph.D. 240-402-9068 WO 75/Rm. 5514

Deputy Director Glen Smith, Ph.D. 240-402-9092 WO 75/Rm. 5722

Division of Immediate Release Products I (DIRPI) Director Vilayat Sayeed, Ph.D. 240-402-9077 WO 75/Rm. 5518

Division of Immediate Release Products II (DIRPII) Director Peter Capella, Ph.D. 240-402-8905 WO 75/Rm. 5510

Division of Modified Release Products (DMRP) Director Bhagwant Rege, Ph.D. 240-402-9064 WO 75/Rm. 5724

Division of Liquid-Based Products (DLBP) Director Bing Cai, Ph.D. 240-402-8902 WO 75/Rm. 5716

Director of Post-Marketing Activities I (DPMAI) Director

Hasmukh Patel, Ph.D. 301-796-1432 WO 21/Rm. 2616

Division of Post-Marketing Activities II (DPMAII) Director Paul Schwartz 240-402-8776 WO 75/Rm. 6720

04/06/18