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Fast track is a designation by the United States Food and Drug Administration (FDA) of an investigational drug for expedited review to facilitate development of drugs that treat a serious or life-threatening condition and fill an unmet medical need. Fast track designation must be requested by the drug company.
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The US Food and Drug Administration (FDA) granted the application for sotorasib orphan drug, fast track, priority review, and breakthrough therapy designations. [5] [11] The FDA granted approval of Lumakras to Amgen Inc. [5] Sotorasib was approved under the FDA's accelerated approval program. [17]
A RMAT designation includes all benefits of the Fast Track and breakthrough therapy designations. In addition, it opens up early interactions between the FDA and sponsors to facilitate accelerated approval. In this context, accelerated approval means approval based on
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FDA Grant Fast Track Designation to ELND005 for the Treatment of Neuropsychiatric Symptoms in Alzheimer's Disease DUBLIN, Ireland--(BUSINESS WIRE)-- Elan Corporation, plc (NYS: ELN) announced ...
[1] [2] A study published in 2023, following a similar study focused on oncology in 2022, suggested that the Accelerated Approval Program was having the intended impact of shortening the timeline to either traditional approval or withdrawal of applications in cases where confirmatory trials had begun before the start of the Accelerated Approval ...
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