What is meant by ” Required Under: Accelerated Approval” in the search results display?
On December 11, 1992, FDA published the final rule to accelerate the approval of new drugs for serious and life-threatening diseases when the drug provides meaningful therapeutic benefit over existing products. Under these procedures, FDA may approve drugs based on surrogate endpoints that reasonably predict that a drug provides clinical benefit. This clinical benefit is then confirmed through additional human studies or clinical trials that will be completed after marketing approval.
