The final version states eligible submissions must demonstrate significant benefits over available treatment options; must not require an advisory committee meeting or new Risk Evaluation and Medication Strategy; and must include clinical trial end points that are “easily interpreted.”
The final version is not significantly different from the drafted guidelines posted July 22, 2022, according to a Nov. 7 report from Regulatory Focus. The final rule clarifies some terminologies, clarifies the eligibility and submission process, and aligns the guidance with the real-time oncology review website. It also rejected calls to expand the guidance to cover cell and gene therapies.
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