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# Real-Time Oncology Review Guidance
- URL: https://www.fdaweb.com/real-time-oncology-review-guidance/
- Published: 2023-11-07T12:00:00.000Z
- Updated: 2026-09-14T14:15:33.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155733

FDA has published a guidance, *Real-Time Oncology Review*, with recommendations to applicants on the process for submitting selected NDAs and BLAs with oncology indications for review under Real-Time Oncology Review (RTOR). The [document](https://www.fda.gov/media/173641/download?ref=fdaweb.com) does not address the agency’s expedited programs and notes that ROTR is separate from the Split Time Application Review pilot that was established under the PDUFA 7 commitments.

The FDA Oncology Center of Excellence and the CDER Office of Oncologic Diseases started RTOR in 2/2018 to facilitate earlier submission of top-line results and datasets to support an earlier start to agency application review, the guidance says. It originally covered only some supplemental oncology drug applications and then was expanded to include select NDAs and BLAs.

“RTOR does not alter the review performance goals and timelines associated with the applications,” FDA says, “including as described in the PDUFA. Although early approvals have occurred with applications included in RTOR, this may not be feasible for all applications due to specific issues that may be identified with the application or overall workload considerations. Acceptance into RTOR does not guarantee or influence approval of the application….”