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# Real-time Oncology Review Draft Guide
- URL: https://www.fdaweb.com/real-time-oncology-review-draft-guide/
- Published: 2022-07-22T12:00:00.000Z
- Updated: 2026-09-14T17:53:00.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5152340

*Federal Register* notice: FDA has made available a draft guidance entitled “Real-Time Oncology Review (RTOR).” The document provides recommendations to applicants on the process for submitting certain NDAs/BLAs with oncology indications for review under the review program. RTOR promotes earlier submission of topline results (i.e., efficacy and safety results from clinical studies before the study report is completed) and datasets, after database lock, to support an earlier review start. It also involves early engagement with the applicant to discuss the submission timelines for RTOR components and the full application submission. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2022-07-22/pdf/2022-15676.pdf?ref=fdaweb.com).