Accelerate drug development and approval for products that address unmet medical needs or provide significant improvement over available therapies
Facilitates the development and expedited review of a drug intended to treat a serious condition for which nonclinical and clinical data demonstrate the potential to address an unmet medical need or a drug that has been designated as a qualified infectious disease product.
Shortens the development and review time when preliminary clinical evidence indicates that a new potential therapy may show substantial improvement on clinically significant endpoints over available therapies for a serious condition.
Accelerates approval for drugs that treat a serious condition and address an unmet medical need based on a surrogate or intermediate clinical endpoint.
Shortens the marketing application review time for a drug that treats a serious condition and demonstrates the potential to provide a significant improvement in safety or effectiveness; it can also: