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  1. Regulatory Science Research and Education

Reorganization of the Office of New Drugs with Corresponding Changes to the Office of Translational Sciences and the Office of Pharmaceutical Quality

Applications Affected by the Reorganization of the Office of New Drugs

In 2017, FDA’s Center for Drug Evaluation and Research (CDER) embarked on an initiative to modernize the New Drugs Regulatory Program.  For more information on this initiative, please visit Modernizing FDA’s New Drugs Regulatory Program.

One critical component of the Modernization includes a reorganization of the New Drugs Regulatory Program. The reorganization of the New Drugs Regulatory Program requires restructuring of the Office of New Drugs (OND) and corresponding changes in the Office of Translational Sciences (OTS) and Office of Pharmaceutical Quality (OPQ).  The approved changes in OND will create offices that align interrelated disease areas, and divisions with clearer and more focused areas of expertise. The changes increase the number of OND offices that oversee our review divisions from six to eight—and increases the number of OND clinical divisions from our current 19 divisions to 27, plus six non-clinical review divisions. In addition to enabling greater efficiency, these envisioned changes will help us to better understand the diseases intended to be treated by the drugs we evaluate for approval – another way we aim to enhance our scientific leadership. OND will also create cross-functional support offices of New Drug Policy, Drug Evaluation Sciences, Regulatory Operations, Operations, and Administrative Operations.

OND’s Reorganization

The reorganization of OND is complete.  The office is now comprised of six cross-functional support offices and eight clinical offices.  The six cross-functional support offices oversee 12 divisions and several staff groups.  The eight clinical offices oversee OND’s 27 clinical divisions and six pharm/tox review divisions.  OND’s offices, divisions, and staffs, along with their respective leaders, are listed below.   The list will be updated as additional selections are made.  Please check back often.

  • Office of New Drugs Immediate Office
    • Office Director: Peter Stein
    • Deputy Director (Clinical): Mary Thanh Hai (Acting)
    • Deputy Director (Operations): Khushboo Sharma
    • Director of Pharmacology/Toxicology: Karen Davis-Bruno
    • Director of Special Programs Staff: Kevin Bugin
       
  • Office of New Drug Policy (ONDP)
    • Office Director: Keith Flanagan
    • Deputy Director: Maarika Kimbrell
       
      • Division of Regulatory Policy (DRP)
        • Division Director:  James Myers
        • Deputy Director:  Katherine Schumann
           
      • Division of Clinical Policy
        • Division Director:  Robert Berlin
        • Deputy Director:  James P. Smith
           
  • Office of Drug Evaluation Sciences (ODES)
    • Office Director: Pending Selection
       
      • Division of Clinical Outcome Assessment (COA)
        • Division Director:  Pending Selection
        • Deputy Director: Pending Selection
           
      • Division of Biomedical Informatics, Research, and Biomarker Development (BIRBD)
        • Division Director:  Pending Selection
        • Associate Director:  Pending Selection
           
  • Office of Therapeutic Biologics and Biosimilars (OTBB)
    • Office Director: Sarah Yim
    • Deputy Director: Emanuela (Manu) Lacana
    • Policy Staff Director: Eva Temkin (Acting)
    • Scientific Review Staff Director:  Stacey Ricci (Acting)
       
  • Office of Program Operations (OPO)
    • Office Director: J. Paul Phillips (Acting)
    • OND Executive Operations Staff Director:  Jewell Martin
    • Learning and Talent Development Staff Director:  Kale Govan (Acting)
    • Business Process Operations Staff Director:  Rachel Kichline 
    • Program Development and Implementation Management Staff Director:  J Paul Phillips 
       
  • Office of Regulatory Operations (ORO)
    • Office Director: Jennifer Mercier
    • Deputy Director: Jacqueline Ware
       
      • Division of Regulatory Operations for Infectious Diseases (DRO-ID)
        • Division Director: Maureen Dillon-Parker (Acting)
        • Chiefs, Project Management Staff (Anti-Infectives):  Maureen Dillon-Parker and Carmen DeBellas
        • Chief, Project Management Staff (Antivirals):  Karen Winestock
           
      • Division of Regulatory Operations for Oncologic Diseases (DRO-OD)
        • Division Director: Melanie Pierce (Acting)
        • Chief, Project Management Staff (Oncology 1):  Christy Cottrell
        • Chief, Project Management Staff (Oncology 2):  Monica Hughes
        • Chief, Project Management Staff (Oncology 3):  Melanie Pierce
        • Chief, Project Management Staff (Hematologic Malignancies 1):  Amy Baird
        • Chief, Project Management Staff (Hematologic Malignancies 2):  Theresa Carioti
           
      • Division of Regulatory Operations for Neuroscience (DRO-ON)
        • Division Director: Paul David (Acting)
        • Chief, Project Management Staff (Neurology I):  Jackie Ware
        • Chief, Project Management Staff (Neurology II):  Jackie Ware
        • Chiefs, Project Management Staff (Psychiatry):  Paul David and Steve Hardeman
        • Chief, Project Management Staff (Anesthesiology, Addiction Medicine, and Pain Medicine):  Matthew Sullivan
           
      • Division of Regulatory Operations for Nonprescription Drugs (DRO-NPD)
        • Division Director:  Celia Peacock (Acting)
        • Chief, Project Management Staff (Nonprescription Drugs I):  Dan Brum
        • Chief, Project Management Staff (Nonprescription Drugs II):  Dan Brum
           
      • Division of Regulatory Operations for Specialty Medicine (DRO-SM)
        • Division Director:  Judit Milstein (Acting)
        • Chiefs, Project Management Staff (Ophthalmology):  Judit Milstein and Dianna Willard
        • Chief, Project Management Staff (Medical Imagining and radiation Medicine):  Kaye Kang
           
      • Division of Regulatory Operations for Cardiology, Hematology, Endocrinology, and Nephrology (DRO-CHEN)
        • Division Director:  Julie van der Waag (Acting)
        • Chief, Project Management Staff (Cardiology and Nephrology):  Ed Fromm
        • Chief, Project Management Staff (Non-Malignant Hematology):  Charlene Wheeler
        • Chiefs, Project Management Staff (Diabetes, Lipid Disorders and Obesity):  Julie van der Waag and Pam Lucarelli
        • Chief, Project Management Staff (General Endocrine):  Julie van der Waag and Pam Lucarelli
           
      • Division of Regulatory Operations for Immunology and Inflammation (DRO-II)
        • Division Director:  Renmeet Grewal (Acting)
        • Chief, Project Management Staff (Rheumatology and Transplant Medicine): Sandy Barnes
        • Chief, Project Management Staff (Pulmonary, Allergy, and Critical Care):  Laden Jafari
        • Chief, Project Management Staff (Gastroenterology):  Renmeet Grewal
        • Chief, Project Management Staff (Hepatology and Nutrition):  Renmeet Grewal
        • Chief, Project Management Staff (Dermatology and Dentistry):  Barbara Gould
           
      • Division of Regulatory Operations for Rare Diseases, Pediatrics, Urologic and Reproductive medicine (DRO-RPURM)
        • Division Director:  Pamela Lucarelli (Acting)
        • Chief, Project Management Staff (Pediatrics and Maternal Health): Rosemary Addy
        • Chief, Project Management Staff (Rare Diseases and Medical Genetics): Pending Selection
        • Chiefs, Project Management Staff (Urology, Obstetrics, and Gynecology):  Margie Kober and Jeannie Roule (Acting)
           
  • Office of Administrative Operations (OAO)
    • Office Director: Pending Selection
    • Deputy Director: Dwayne Keels (Acting)
    • Financial Services Staff Director:  Helena Ngo (Acting) 
    • Administrative Analysis Staff Director:  Sharon Miller (Acting)
    • Administrative Operations Staff 1 Director:  Lisa Wiederock 
    • Administrative Operations Staff 2 Director:  Jeanne Tirado 
    • Administrative Operations Staff 3 Director:  Krista Yazdani 
    • Administrative Operations Staff 4 Director:  Ryan Fitzgibbons 
    • Administrative Operations Staff 5 Director:  Amanda Mickley (Acting)
       
  • Office of Infectious Diseases (OID)
    • Office Director: John Farley (Acting)
    • Deputy Director: Adam Sherwat (Acting)
       
      • Division of Anti-Infectives (DAI)
        • Division Director: Sumathi Nambiar
        • Deputy Director: Dmitri Iarikov
        • Deputy Director for Safety:  Pending Selection
           
      • Division of Antivirals (DAV)
        • Division Director: Debra Birnkrant
        • Deputy Director: Jeffrey Murray
        • Deputy Director for Safety: Poonam Mishra
           
      • Division of Pharm/Tox for Infectious Diseases (DPTO-ID)
        • Division Director: Hanan Ghantous (Acting)
           
  • Office of Oncologic Diseases (OOD)
    • Office Director: Rick Pazdur (Acting)
    • Office Deputy Director: Marc Theoret (Acting)
    • Supervisory Associate Director for Safety: Meredith Chuk (Acting)
    • Associate Directors for Safety: Shaily Arora (Acting), Shanthi Marur (Acting), Abhilasha Nair (Acting)
       
      • Division of Oncology I (DO I)
        • Division Director: Julia Beaver
        • Deputy Director: Amna Ibrahim
           
      • Division of Oncology Products II (DO II)
        • DO II Division Director: Harpreet Singh (Acting)
        • DO II Deputy Director: Pending Selection
           
      • Division of Oncology Products III (DO III)
        • DO III Division Director: Steven Lemery (Acting)
        • DO III Deputy Director: Lola Fashoyin-Aje (Acting)
           
      • Division of Hematologic Malignancies I (DHM I)
        • DHM I Division Director: Angelo DeClaro (Acting)
        • DHM I Deputy Director: Pending Selection
           
      • Division of Hematologic Malignancies II (DHM II)
        • DHM II Division Director: Nicole Gormley (Acting)
        • DHM II Deputy Director: Pending Selection
           
      • Division of Hematology Oncology Toxicology (DHOT)
        • Division Director: John Leighton
        • Deputy Director: Haleh Saber
           
  • Office of Neuroscience (ON)
    • Office Director: Billy Dunn (Acting)
    • Deputy Director: Eric Bastings (Acting)
       
      • Division of Neurology I (DN I)
        • Division Director: Eric Bastings (Acting)
        • Deputy Director:  Teresa Buracchio (Acting)
        • Deputy Director for Safety: Pending Selection
           
      • Division of Neurology II (DN II)
        • Division Director: Nick Kozauer (Acting)
        • Deputy Director: Paul Lee (Acting)
        • Deputy Director for Safety: Alice Hughes
           
      • Division of Psychiatry
        • Division Director: Tiffany Farchione (Acting)
        • Deputy Director: Bernie Fischer (Acting)
        • Deputy Director for Safety: Marc Stone
           
      • Division of Anesthesiology, Addiction Medicine, and Pain Medicine (DAAP)
        • Division Director: Rigoberto Roca (Acting)
        • Deputy Director: Naomi Lowy (Acting)
        • Deputy Director for Safety: Judith Racoosin
           
      • Division of Pharm/Tox for Neuroscience (DPT-ON)
        • Division Director: Lois Freed
        • Deputy Director: Dann Mellon (Acting)
           
  • Office of Nonprescription Drugs (ONPD)
    • Office Director: Terri Michele (Acting)
    • Deputy Office Director: Karen Mahoney (Acting)
       
      • Division of Nonprescription Drug Products I (DNPD I)
        • Division Director:  Karen Mahoney (Acting)
        • Deputy Director:  Nushin Todd
        • Deputy Director for Safety: Valerie Pratt
           
      • Division of Nonprescription Drug Products II (DNPD II)
        • Division Director:  Francis Becker (Acting)
        • Deputy Director:  Pending Selection
        • Deputy Director for Safety: Evelyn Mentari (Acting)
           
      • Division of Pharm/Tox for Nonprescription Drugs (DPT-NPD)
        • Division Director: Paul Brown
           
  • Office of Specialty Medicine (OSM)
    • Office Director: Charles Ganley
    • Office Deputy Director: Alex Gorovets (Acting)
    • Associate Director of Pharmacy Compounding: Daiva Shetty (Acting)
       
      • Division of Ophthalmology (DO)
        • Division Director: Wiley Chambers (Acting)
        • Deputy Director: Pending Selection
        • Deputy Director for Safety: Pending Selection
           
      • Division of Medical Imaging and Radiation Medicine (DMIRM)
        • Division Director: Libero Marzella 
        • Deputy Director: Pending Selection
        • Deputy Director for Safety: Ira Krefting
           
  • Office of Cardiology, Hematology, Endocrinology, and Nephrology (OCHEN)
    • Office Director: Ellis Unger
    • Office Deputy Director: Ilan Irony (Acting)
       
      • Division of Cardiology and Nephrology (DCN)
        • Division Director:  Norman Stockbridge
        • Deputy Director: Aliza Thompson
        • Deputy Director for Safety: Mary Ross Southworth
           
      • Division of Non-Malignant Hematology (DNH)
        • Division Director:  Ann Farrell
        • Deputy Director: Albert Deisseroth (Acting)
        • Deputy Director for Safety: Rosanna Setse (Acting)
           
      • Division of Diabetes, Lipid Disorders, and Obesity (DDLO)
        • Division Director: Lisa Yanoff (Acting)
        • Deputy Director: Pending Selection
        • Deputy Director for Safety: Pending Selection
           
      • Division of General Endocrinology (DGE)
        • Division Director: Theresa Kehoe (Acting)
        • Deputy Director: Pending Selection
        • Deputy Director for Safety: Pending Selection
           
      • Division of Pharm/Tox for Cardiology, Hematology, Endocrinology, and Nephrology (DPT-CHEN)
        • Division Director:  Todd Bourcier (Acting)
           
  • Office of Immunology and Inflammation (OII)
    • Office Director: Julie Beitz
    • Office Deputy Director: Pending Selection
       
      • Division of Rheumatology and Transplant Medicine (DRTM)
        • Division Director: Nikolay Nikolov (Acting)
        • Deputy Director: Pending Selection
        • Deputy Director for Safety: Ozlem Belen
           
      • Division of Pulmonology, Allergy, and Critical Care (DPACC)
        • Division Director: Sally Seymour
        • Deputy Director: Pending Selection
        • Deputy Director for Safety: Pending Selection
           
      • Division of Gastroenterology (DG)
        • Division Director: Jessica Lee (Acting)
        • Deputy Director: Pending Selection
        • Deputy Director for Safety: Joyce Korvick
           
      • Division of Hepatology and Nutrition (DHN)
        • Division Director: Joseph Toerner (Acting)
        • Deputy Director: Pending Selection
        • Deputy Director for Safety: Pending Selection
           
      • Division of Dermatology and Dentistry (DDD)
        • Division Director: Kendall Marcus
        • Deputy Director: Shari Targum (Acting)
        • Deputy Director for Safety: Tatiana Oussova
           
      • Division of Pharm/Tox for Immunology and Inflammation (DPT-OII)
        • Division Director:  Andrew Goodwin (Acting)
           
  • Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine (ORPURM)
    • Office Director: Hylton Joffe (Acting)
    • Office Deputy Director: Pending Selection
       
      • Division of Pediatrics and Maternal Health (DPMH)
        • Division Director: Lynne Yao
        • Deputy Director: John Alexander
           
      • Division of Rare Diseases and Medical Genetics (DRDMG)
        • Division Director: Kathleen (Katie) Donohue (Acting)
        • Deputy Director: Pending Selection
        • Associate Director for Rare Diseases: Pending Selection
        • Deputy Director for Safety: Pending Selection
           
      • Division of Urology, Obstetrics, and Gynecology (DUOG)
        • Division Director: Christine Nguyen (Acting)
        • Deputy Director: Audrey Gassman
        • Deputy Director for Safety: Pending Selection
           
      • Division of Pharm/Tox for Rare Diseases, Pediatrics, Urologic and Reproductive medicine (DPT-ORPURM/SM)
        • Division Director:  Mukesh Summan (Acting)

Changes within other New Drugs Regulatory Program offices

  • The Office of Translational Sciences (OTS) will align to support the clinical structure within OND.  OTS’ overarching rationale for the reorganization is to achieve minimal disruption and enhance OND alignment. The Office of Biostatistics (OB) will reorganize from 8 to 9 therapeutically aligned divisions. The Office of Clinical Pharmacology, will reorganize from current 5 to 7 therapeutically aligned divisions. In both offices, cross-cutting functions will be consolidated for better review quality and process efficiency. The OTS Immediate Office will establish an Office of Administrative Operations.
  • The Office of Pharmaceutical Quality (OPQ): is changing their structure to better align within OPQ, with the New Drug Regulatory Program modernization, and with other groups in CDER. The modernization efforts created a window of opportunity to re-vision and reorganize some parts of OPQ while maintaining its core work functions.  OPQ is establishing a new OPQ Office of Administrative Operations, renaming two existing OPQ offices, and creating seven new divisions across OPQ. 

  • The Office of Surveillance and Epidemiology (OSE) will realign within teams and does not require reorganization.

Who to contact for more information about the reorganization of OND or the NDRP Modernization?

For more information on the reorganization of OND or the NDRP Modernization, please email druginfo@fda.hhs.gov

Reorganization Questions and Answers

  1. I have questions about the reorganization. Where can I get additional information?

    We will post information and updates on the reorganization on the Reorganization of the Office of New Drugs with Corresponding Changes to the Office of Translational Sciences and the Office of Pharmaceutical Quality website. If you have specific questions, please reach out to druginfo@fda.hhs.gov
  1. How will this affect processes and communications with industry? Will FDA contacts change?

    We are conducting assessments of risk and preparing across our operations to ensure that our interactions with industry are minimally affected. Our communications will increase during the reorganization process to assure industry stays up to date with any changes to responsible organizations of their applications (i.e., INDs and NDA/BLAs), and any changes to points of contact. A website with information on the reorganization, the implementation plan, changes to FDA points of contact, application assignments, and additional resources will be launched coinciding with the reorganization’s start. We encourage industry to review the website carefully and check back throughout the reorganization process.
  1. Will my NDA or BLA applications that are currently in review by OND divisions be affected?  If so, how?

    Review teams will not change. However, the responsible division and signatory responsible for NDA and BLA applications under review may change – this will be determined by several factors, including how far along the review of the application is at the time of the reorganization of that division. If there is a change in responsible organization, signatory or point of contact for applications currently under review, then Sponsors will be notified. At the start of each phase, Sponsors can also see if their applications are affected by the reorganizations of that phase by viewing the list of application (INDs and NDA/BLAs) numbers and the associated point person on the NDRP Modernization Reorganization webpage.
  1. As a result of the reorganization, will there be changes to CDER Manual of Policies and Procedures (MAPPs) as well as guidance documents related to INDs and NDA/BLA marketing applications?

    CDER Manual of Policies and Procedures and guidance documents related to INDs and NDA/BLA marketing applications may be updated as a result of the reorganization to reflect updated organizational titles and processes. These administrative updates are not expected until the reorganization is complete. Updated documents and policies and procedures will be posted on the FDA website.
  1. Will there be changes in the way CDER communicates and interacts with sponsors?

    The reorganization will not directly change the way CDER communicates and interacts with sponsors. However, we believe that these changes to the organizational structure of the New Drugs Regulatory Program will enable CDER to communicate in a more efficient and effective way with Sponsors.
  1. When will CDER update their webpages to reflect these organizational changes?

    These updates will be completed over the course of the reorganization, with updates to websites coinciding with the reorganization of structures.

 

Additional information on the goals of modernization

 

Return to Modernizing FDA's New Drugs Regulatory Program

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