Snapshot

The FDA Accelerated Approval pathway has been developed by the US Food and Drug Administration of United States.

This pathway can be used where Accelerated approval is generally used in settings of unmet medical need for drugs intended for the treatment of a serious or life-threatening condition. FDA’s accelerated approval regulations state that accelerated approval is available only for drugs that provide a meaningful therapeutic benefit over existing treatments, and the FD&C Act was subsequently amended to require that FDA consider “the severity, rarity, or prevalence of the condition and the availability or lack of alternative treatments” when approving a product under accelerated approval. Accelerated approval allows sponsors to obtain approval with data that demonstrate efficacy based on surrogate or intermediate clinical endpoints that are reasonably likely to predict clinical benefit for the condition. This often allows sponsors to obtain approval for products intended to treat an unmet medical need sooner than would be possible under traditional approval. .

This pathway facilitates activities during development and accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

Target time assessment is Info not found.