Accelerated Approval

Accelerated Approval is a regulatory pathway used by the FDA to fast-track the approval of drugs for serious conditions, especially when there are few or no effective treatments available. It allows drugs to be approved based on early evidence that they may provide benefit, rather than waiting for all the usual long-term clinical trial data. This approach helps patients access potentially life-saving therapies sooner, but it requires that further studies confirm the drug’s benefits after approval. If these studies fail to validate the initial promise, the drug may face withdrawal from the market.