Center for Global Health R&D Policy Assessment

Determining the clinical outcome for a new health technology, that is whether a patient’s health improves and in what way, can take significant time, even years. The Accelerated Approval program of the FDA allows companies to reach a clinical surrogate, a physical sign or laboratory measurement, to determine clinical effectiveness. This can reduce valuable review time and allow companies to reap the benefits of their innovation more quickly. The FDA reserves the right to remove the product from the market if confirmatory trials do not align with the original testing.