About FDA
Office of Generic Drugs: Phone Directory
Division of Labeling and Program Support (DLPS)
- Division of Chemistry I (DCI)
- Division of Chemistry II (DCII)
- Division of Chemistry III (DCIII)
- Division of Chemistry IV (DCIV)
- Division of Bioequivalence I (DBI)
- Divison of Bioequivalence II (DBII)
Division of Clinical Review (DCR)
Phone: 240-276-9310 Fax: 240-276-9327
Kathleen Uhl, M.D., Acting Director, Office of Generic Drugs
Robert L. West, Deputy Director, HFD-601
Phone: 240-276-8402 Fax: 240-276-8428
Robert Lionberger, Ph.D., Acting Deputy Director for Science, HFD-600
Susan Rosencrance, Ph.D., Acting Deputy Director for Chemistry, HFD-600
Frank O. Holcombe, Jr., Ph.D., Associate Director for Chemistry, HFD-600
Saundra Middleton, Senior Science Policy Analyst, HFD-600
Cecelia Parise, Regulatory Policy Advisor, HFD-600
Thomas Hinchliffe, Pharm.D., Special Assistant to the Director for GDUFA Implementation, HFD-600
Division of Labeling and Program Support (DLPS)
Phone: 240-276-8400 Fax: 240-276-8943
Wm. Peter Rickman, Director, HFD-610, 240-276-8944
Harvey Greenberg, Special Assistant, HFD-612, 240-276-8975
Robert Reinwald, Orange Book Team Leader, HFD-615
Phone: 240-276-8969 Fax: 240-276-8974
Timothy W. Ames, Approvals Manager, Branch Chief, Review Support Branch, HFD-617
Phone: 240-276-8459 Fax: 240-276-8455
Simon Eng, Pharm.D., Pivot Project Manager, (240-276-8529), FAX 240-276-8504
Labeling
Labeling Team Team Leader Chemistry Division Phone Fax 1 John Grace I 240-276-8985 240-276-8999 2 Koung Lee II 240-276-8981 240-276-8999 3 Ruby Wu III 240-276-8952 240-276-8999 4 Lillie Golson IV 240-276-8994 240-276-8999
Labeling Team Reviewers
Corresponding CMC Team Labeling Reviewer Phone 11 Ann Vu 240.276-8991 12 Angela Payne 240-276-8983 13 Beverly Weitzman 240-276-8984 14 Charles Hoppes 240-276-8988 21 Chan Park 240-276-8951 22 Adolph Vezza 240-276-8987 23 Sarah Park 240-276-8995 24 James Barlow 240-276-8979 31 Burhan Nour 240-276-8990 32 Lisa Kwok 240-276-8980 33 Jeanne Skanchy 240-276-8997 34 Betty Tunner 240-276-8728 41 Melanie Shin and Theresa Liu 240-276-8976/240-276-8898 42 TBD 240-276-8962 43 Jacqueline Council and Soon Oh 240-276-8989/240-276-8996 44 Malik Imam 240-276-8964
New Chemistry Project Managers Structure*
| Division of Chemistry | Team | PQRPM (Product Quality Regulatory Project Manager) | RPM (Regulatory Project Manager) |
|---|---|---|---|
| I | 11/14 | Rinku Patel, Pharm.D. | Christina Kirby, Pharm.D. |
| I | 12/13 | Tania Mazza, Pharm.D. | Esther Chuh, Pharm.D./Trang Tran, Pharm.D. |
| II | 21/24 | Frank Nice, R.Ph. | Erlin Lee, Pharm.D., Linda Park, Pharm.D. |
| II | 22/23 | Tina Nhu, Pharm.D./Ryan Presto, Pharm.D. | Sean Belouin, Pharm.D. |
| III | 31/32 | Steve Yang, Pharm.D. | Sarah Nguyen, Pharm.D. |
| III | 33/34 | Leigh Ann Sears, R.N. | Robert Gaines, Pharm.D. |
| IV | 41/43 | Mark Gonitzke, R.Ph. | Dat Doan, Pharm.D. |
| IV | 42/44 | Vincent Sansone, Pharm.D. | Andrew Kim, Pharm.D. |
Chemistry Project Manager Directories
| Project Manager | Phone | Fax |
|---|---|---|
| Christina Kirby, Pharm.D. | 240-276-8573 | 240-276-8504 |
| Esther Chuh, Pharm.D. | 240-276-8530 | 240-276-8503 |
| Trang Tran, Pharm.D. | 240-276-8518 | 240-276-8503 |
| Benjamin Danso, Pharm.D. | 240-276-8527 | 240-276-8503 |
| Frank Nice, R.Ph., DPA, CPHP | 240-276-8555 | 240-276-8582 |
| Tina Nhu, Pharm.D. | 240-276-8548 | 240-276-8582 |
| Sean Belouin, Pharm.D. | 240-276-8566 | 240-276-8582 |
| Linda Park, Pharm.D. | 240-276-8536 | 240-276-8504 |
| Sarah Nguyen, Pharm.D. | 240-276-8467 | 240-276-8474 |
| Steven Yang, Pharm.D. | 240-276-8476 | 240-276-8474 |
| Robert Gaines, Pharm.D. | 240-276-8495 | 240-276-8474 |
| Leigh Ann Sears, R.N. | 240-276-8453 | 240-276-8474 |
| Dat Doan, R.Ph. | 240-276-9336 | 240-276-8440 |
| Mark Gonitzke, R.Ph. | 240-276-8422 | 240-276-844 |
| Andrew Kim, Pharm.D. | 240-276-8438 | 240-276-8440 |
| Erin Lee, Pharm.D. | TBD | |
| Tania Mazza | 240-276-8506 | |
| Rinku Patel, Pharm.D. | 240-276-9279 | |
| Vincent Sansone, Pharm.D. | 240-276-8137 | 240-276-8440 |
Regulatory Support
Fax: 240-276-8943
Branch Chief Martin Shimer, III 240-276-8675 Team Member Kwadwo Awuah, Pharm.D., RAC 240-276-8678 Peter Chen, R.Ph. 240-276-8977 Rebekah Granger 240-276-8973 Shannon Hill, Pharm.D. 240-276-8650 Timothy Jetton, R.Ph. 240-276-8967 Ian Margand, Pharm.D. 240-276-8676 Ted Palat, Pharm.D. 240-276-8982 Molly MacDonnell, Pharm.D. 240-276-8679 Linh Vo, R.Ph. 240-276-8978 Julie Lee, Pharm.D. 240-276-8724 Johnny Young 240-276-8677 Kevin Ninan, Pharm.D. 240-276-8953
Division of Chemistry I
Phone: 240-276-8500 Fax: 240-276-8504
Division of Chemistry II
Phone: 240-276-8505 Fax: 240-276-8582
Division of Chemistry III
Phone: 240-276-8444 Fax: 240-276-8474
Division of Chemistry IV
Phone: pending Fax: pending
| Division | Team | Division Director | Team Leader | Chemistry Project Manager |
|---|---|---|---|---|
| I | 11 | Andre Raw | Bita Mirzari-Azam | Rinku Patel |
| I | 12 | Bhagwant Rege | Tania Mazza | |
| I | 13 | James Fan | Tania Mazza | |
| I | 14 | Raj Bykadi | Rinku Patel | |
| II | 21 | Glen Smith | Radhika Rajagopalan | Frank Nice |
| II | 22 | Ubrani Venkataram | Tina Nhu/Ryan Presto | |
| II | 23 | Peter Capella | Tina Nhu/Ryan Presto | |
| II | 24 | Bing Wu | Frank Nice | |
| III | 31 | Vilayat Sayeed | Guoping Sun | Steven Yang |
| III | 32 | Latiff Hussain | Steven Yang | |
| III | 33 | Suhas Patankar | Leigh Ann Sears | |
| III | 34 | Laxma Nagavelli | Leigh Ann Sears | |
| IV | 41 | Robert Iser | Al Mueller | Mark Gonitzke |
| IV | 42 | Huijeong Jung | Vincent Sansone | |
| IV | 43 | Susan Zuk | Mark Gonitzke | |
| IV | 44 | Upinder Atwal | Vincent Sansone |
- OGD RPM re-structure pictorial diagram (PDF - 23KB)
Fax: 240-276-8825
Neal Sweeney, Ph.D., Director, Division of Microbiology
Lynne A. Ensor, Deputy Director, Division of Microbiology
| Microbiology Team | Microbiology Team Leader | Project Manager |
|---|---|---|
| 1 | Marla Steven-Riley, Ph.D. (Acting) | TBD (240-276-8831) |
| 2 | Brenda Pillari, Ph.D. | Craig Kiester (240-276-8722) |
| 3 | Paul Dexter, M.S. | Craig Kiester |
Division of Bioequivalence I
Phone: 240-276-8782 Fax: 240-276-8766
Divison of Bioequivalence II
Phone: 240-276-8817 Fax: 240-276-8766
| Division of Bioequivalence | Team | Division Director | Team Leader | Project Manager | Supervisory PM |
|---|---|---|---|---|---|
| I | 2 | Dale Conner, Pharm.D. | Nilufer Tampal, Ph.D. | Sherry Chang, Pharm.D. | Teresa Ramson, Pharm.D. |
| I | 4 | Bing Li, Ph.D. | Sherry Chang, Pharm.D. | ||
| I | 6 | Shriniwas Nerurkar, Ph.D. | Martin Yoon, Pharm.D. | ||
| I | 8 | April Braddy, Ph.D. | Martin Yoon, Pharm.D. | ||
| I | 10 | Utpal Munshi, Ph.D. | Diana Solana-Sodeinide, Pharm.D. | ||
| II | 1 | Barbara Davit, Ph.D. | Partha Chandarory, Ph.D. | Nabeel Babaa, Pharm.D. | Aaron Sigler, Pharm.D. |
| II | 3 | Moheb Makary, Ph.D. | Scott Vehovic, R.Ph. | ||
| II | 5 | Chandra Chaurasia, Ph.D. | Duong (Diane) Nhu, Pharm.D. | ||
| II | 7 | Xiaojian Jiang, Ph.D. | Chitra Mahadevan, Pharm.D. | ||
| II | 9 | Kuldeep Dhariwal, Ph.D. | Jessica Kreger, Pharm.D. |
John Peters, M.D., Director, 240-276-8670
Nitin K. Patel, Pharm.D., Medical Affairs Coordinator, 240-276-8670
Debra Catterson, R.Ph., Clinical Safety Coordinator, 240-276-8963
