USA – FDA offers details on PDUFA VII STAR review pilot

The US Food and Drug Administration (FDA) has announced details on its Split Real Time Application Review (STAR) pilot, a program designed to shorten the review time of existing drugs and biologics where there is an unmet medical need so patients can access the therapies earlier.

The program would apply to “efficacy supplements across all therapeutic areas and review disciplines that meet specific criteria,” the agency wrote on a new web page. The program includes supplemental new drug applications (sNDAs) and supplemental biologics license applications (sBLAs) with new potential uses for already approved therapies.

Much of the information on the eligibility criteria for the STAR pilot had already been outlined in the agency’s commitment letter containing performance goals and procedures for the Prescription Drug User Fee Act (PDUFA) for 2023–2027, also known as PDUFA VII (RELATED: Rare diseases, STAR expansion considered in PDUFA VII premarket negotiationsRegulatory Focus 16 April 2021). However, FDA added a few clarifying points to the website elaborating on eligibility criteria for STAR pilot applicants…