Pilot Evaluating Quicker Reviews for Some Drugs

FDA is announcing a new opportunity for drug companies to participate in a pilot program designed to expedite the review of new therapies addressing unmet medical needs. Starting 12/2 , CDER and CBER will each accept one to two original marketing applications as part of the STAR pilot program. The agency’s user fee program mandated the pilot to evaluate granting earlier access to treatments that show substantial improvements over existing options for serious conditions.

To qualify for the pilot, an FDA notice says applicants must demonstrate clinical evidence that the treatment offers a significant improvement in patient outcomes compared to available therapies. Submissions must also target serious health conditions with limited treatment options. Additionally, applications with complex requirements, such as new risk management plans or the need for foreign manufacturing inspections, are ineligible for the accelerated review.