15 January 2026 - The US FDA said there is "minimal industry interest" from companies to participate in its Split Real Time Application Review (STAR) pilot program for drugs and biologics. Companies that have sought to participate have witnessed a high rate of rejections.

“Despite several FDA presentations on STAR, and the program's availability across all therapeutic areas and review disciplines in CDER and CBER, FDA observed minimal industry interest in the program during the assessment period, as evidenced by the limited number of STAR Entry requests received. Additionally, none of the requests received met the criteria for acceptance into the pilot program. As a result, FDA received no applications in the pilot program as of the end of FY2025,” FDA said.

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