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# Accelerated Approval On- and Off-Ramp Approaches
- URL: https://www.fdaweb.com/accelerated-approval-on-and-off-ramp-approaches/
- Published: 2022-09-22T12:00:00.000Z
- Updated: 2026-09-14T18:00:10.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152799

Staff in the FDA Oncology Center of Excellence say new procedures are needed for oncology drug accelerated approvals to shorten the time between approval and the completion of a confirmatory study. “The time between accelerated approval and verification or refutation of clinical benefit is a period of uncertainty,” the staffers [write](https://www.nejm.org/doi/10.1056/NEJMp2208954?ref=fdaweb.com) in the *New England Journal of Medicine*. “The pathway’s success should be measured in part by the length of this period…. Public discussion has focused on improving the accelerated approval off-ramp, suggesting specific time limits for completing confirmatory trials, patient enrollment milestones for evaluating timely trial completion, and alternative procedures for withdrawing indications. But equally important are procedures to build quality and efficiency into the accelerated approval on-ramp, which should include a prospective comprehensive strategy detailing plans for accelerated approval and the verification of clinical benefit, with the aim of expanding therapeutic advances and shortening this period of uncertainty.”