U.S. flag An official website of the United States government
  1. Home
  2. Drugs
  3. Regulatory Science Research and Education
  4. Reorganization of the Office of New Drugs with Corresponding Changes to the Office of Translational Sciences and the Office of Pharmaceutical Quality
  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.

Overall OND Structure

PDF Version


Clinical and Pharm/Tox Structure

PDF Version

OND’s Implementation of the Reorganization

The changes to the structure of OND will occur in four phases, as described below.  Please check back regularly for updates on the timing of each phase.

Phase I: October/November 2019 (Target Start: October 1st)

  • The Office of New Drug Policy (ONDP), Office of Program Operations (OPO), Office of Drug Evaluation Sciences (ODES), and the immediate offices of Office of Regulatory Operations (ORO) and Office of Administrative Operations (OAO) will be “stood up.”

Phase II:  November/December 2019 (Target Start:  November 4th)

The Office of Antimicrobial Products (OAP) will become the Office of Infectious Diseases (OID)

  • Division of Anti-Infective Products (DAIP) will become the Division of Anti-Infectives (DAI)
  • Division of Anti-Viral Products (DAVP) will become the Division of Antivirals (DAV)
  • Division of Pharm/Tox For Infectious Diseases (DPT-ID) will be formed from Pharm/Tox personnel currently in the OAP divisions
  • A Division of Regulatory Operations for Infectious Diseases (DRO-ID) will be comprised of regulatory staff from the corresponding clinical Divisions in this Office and will report to ORO

The Office of Hematology and Oncology Products (OHOP) will become the Office of Oncologic Diseases (OOD)

  • Division of Oncology Products I & II (DOP I & II) will be split into 3 divisions (DO I, II, & III)
  • Division of Hematology Products (DHP) will be split into Division of Hematologic Malignancies I & II (DHM I & II)
  • Division of Hematology Oncology Toxicology (DHOT) will keep the same name in the new Office of Oncologic Diseases (OOD)
  • A Division of Regulatory Operations for Oncologic Diseases (DRO-OD) will be comprised of regulatory staff from the corresponding clinical Divisions in this Office and will report to ORO

The Office of Neuroscience (ON) will be formed from select Divisions in the Office of Drug Evaluation I, II

  • Division of Neurology Products (DNP) will split into Division of Neurology I & II (DN I & II)
  • Division of Psychiatry Products (DPP) will become Division of Psychiatry (DP)
  • Division of Anesthesia, Analgesia, and Addiction Products (DAAAP) will become Division of Anesthesiology, Addiction Medicine, and Pain Medicine (DAAP)
  • Division of Pharm/Tox for Neuroscience (DPT-N) will be formed from Pharm/Tox personnel currently in divisions forming ON
  • A Division of Regulatory Operations for Neuroscience (DRO-N) will be comprised of regulatory staff from the corresponding clinical Divisions in this Office and will report to ORO

Phase III: December 2019/January 2020 (Target Start: December 2nd)

The Office of Nonprescription Drugs (ONPD) will be formed from the Division of Non-prescription Drug Products in the Office of Drug Evaluation IV

  • Division of Non-prescription Drug Products (DNDP) will be split into two divisions (DNPD I and DNPD II)
  • A Division of Regulatory Operations for Non-prescription Drugs (DRO-NPD) will be comprised of regulatory staff from the corresponding clinical Divisions and will report to ORO     
  • Non-clinical staff for ONPD will report to the immediate office of ONPD

The Office of Specialty Medicine (OSM) will be formed from Divisions in the Office of Antimicrobial Products (OAP), and the Office of Drug Evaluation IV

  • Select staff from the Division of Transplant and Ophthalmology Products (DTOP) will transition to the Division of Ophthalmology (DO)
  • Division of Medical Imaging Products (DMIP) will become the Division of Medical Imaging and Radiation Medicine (DMIRM)
  • The newly created Division of Pharm/Tox of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine (DPT-RPURM) will also provide Pharm/Tox support to the office of specialty medicine once ORPURM but is stood up in Phase IV. Non-clinical staff will remain with their original supervisors from original Divisions until Phase IV.
  • A Division of Regulatory Operations for Specialty Medicine (DRO-SM) will be comprised of regulatory staff from the corresponding clinical Divisions in this Office and will report to ORO

Phase IV: February/March 2020 (Target Start:  February 3rd)

The Office of Cardiology, Hematology, Endocrinology, & Nephrology (OCHEN) will be formed from Divisions in the Office of Drug Evaluation I, II, III, and the Office of Hematology and Oncology Products

  • Division of Cardiovascular and Renal Products (DCRP) will become the Division of Cardiology and Nephrology (DCN)
  • Division of Non-Malignant Hematology (DNH) will be formed as a new division with personnel from the Division of Hematology Products (DHP)
  • Select staff from the Division of Metabolism and Endocrinology Products (DMEP) will become the Division of Diabetes, Lipid, Disorders, and Obesity (DDLO)
  • Select staff from the Division of Bone, Reproductive, and Urologic Products (DBRUP) and Division of Metabolism and Endocrinology Products (DMEP) will become the Division of General Endocrinology (DGE)
  • Division of Pharm/Tox for Cardiology, Hematology, Endocrinology, and Nephrology (DRO-CHEN) will be formed from Pharm/Tox personnel currently in Divisions forming OCHEN
  • A Division of Regulatory Operations for Cardiology, Hematology, Endocrinology, & Nephrology, (DRO-CHEN) will be comprised of regulatory staff from the corresponding clinical Divisions in this Office and will report to ORO

The Office of Immunology and Inflammation (OII) will be formed from divisions in the Office of Drug Evaluation II, III and the Office of Antimicrobial Products

  • Select staff from the Division of Transplant and Ophthalmology Products (DTOP) and the Division of Pulmonary, Allergy, Rheumatology Products (DPARP) will form the Division of Rheumatology and Transplant Medicine (DRTM)
  • Select staff from the Division of Pulmonary, Allergy, and Rheumatology Products (DPARP) will become the Division of Pulmonology, Allergy, and Critical Care (DPACC)
  • Select staff from the Division of Gastroenterology and Inborn Errors Products (DGIEP) will form the Division of Gastroenterology (DG) and the Division of Hepatology and Nutrition (DHN)
  • Division of Dermatology and Dental Products (DDDP) will become the Division of Dermatology and Dentistry (DDD)
  • Division of Pharma/Tox for Immunology and Inflammation (DPT-II) will be formed from Pharm/Tox personnel currently in divisions forming OII
  • A Division of Regulatory Operations for Immunology & Inflammation (DRO-II) will be will be comprised of regulatory staff from the corresponding clinical Divisions in this Office and will report to ORO

The Office of Rare Diseases, Pediatrics, Urologic, & Reproductive Medicine (ORPURM) will be formed from divisions in the Office of Drug Evaluation III, IV

  • Division of Pediatrics and Maternal Health (DPMH) will be aligned to ORPURM in the new structure 
  • Select staff from the Division of Gastroenterology and Inborn Errors Products (DGIEP) will form the Division of Rare Diseases and Medical Genetics (DRDMG)
  • Select staff from the Division of Bone, Reproductive, and Urologic Products (DBRUP) focused on Urologic, Obstetric and Gynecologic Products will form the new Division of Urology, Obstetrics, and Gynecology (DUOG)
  • Division of Pharm/Tox of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine (DPT- RPURM) will be a newly formed division with shared P/T support to OSM
  • Division of Regulatory Operations for Rare Diseases, Pediatrics, Urologic, and Reproductive Medicine (DRO-RPURM) will be will be comprised of regulatory staff from the corresponding clinical Divisions in this Office and will report to ORO

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