Snapshot

The Plausible Mechanism Pathway pathway has been developed by the of United States.

This pathway can be used where personalized therapies for ultra-rare diseases to be approved based on evidence of a clear biological mechanism and measurable patient benefit, even without traditional randomized clinical trials. The biological cause of the disease must be known..

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

Target time assessment is Information not yet available. .