Reorganization of FDA’s Oncology Products Reviewers Affects IND and NDAs
[Thursday, November 7, 2019]

In its ongoing reorganization efforts to align the review and oversight activities with the changing landscape of the products it regulates, FDA announced a major reorganization of its oncology product review divisions by renaming the main office to Office of Oncologic Diseases (ODD) and creating 6 new divisions within the office each focused on fewer specific cancer types than the previous 4 divisions, and the review of non-malignant hematology products was moved out of oncology review divisions. Of the 6 new divisions, 5 will review new clinical products while one will review non-clinical toxicology issues. In addition to the new divisions in the OOD, 5 special sub-offices were created within the Office of Regulatory Affairs (ORA), one for each of the newly created clinical oncology divisions called the ORA-OD1 through OD-5. These reorganizations are a part of the ongoing Agency-wide reorganizations planned to be completed by March next year. Most of these internal organization require the sponsors to do more than just remember a few new acronyms. All INDs and NDA/BLA applications, including all submissions and meeting requests, will be handled by the respective ORA-ODs. Going forward, the new pre-IND meeting requests and INDs are required to be specifically addressed to the relevant division with specific subject lines in cover letters based on the target indication(s). The ongoing INDs and NDA/BLA applications will be moved based on the new division assignments, and project management staff for a given application may change. It would be expected that the reviewers working on a given application will continue working although it is possible that some applications may transition to new review teams. Sponsors should ideally not see any major impact on the review of their applications but due to the reorganization, sponsors may need to file additional INDs based on the new review divisions in charge of a given indication. Since cancer drugs are frequently investigated for multiple cancer indications, sponsors would likely need multiple INDs for the various indications. Again, the overall programs may not get impacted in any significant way but the regulatory project management staff at the sponsors would likely be busier.