This NDA was accepted for review under the FDA's Real-Time Oncology Review (RTOR) pilot program, which aims to explore a more efficient review process to ensure safe and effective treatments are available to patients as early as possible. The FDA granted priority review and set an action date of February 28, 2021 under the Prescription Drug User Fee Act.
Will B-drug qualify for this special FDA treatment?
Medical / Clinical Discussions, page-197
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