Eye on FDA
A series focused on important FDA and related regulatory developments critical to the life sciences industry.
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Eye on FDA
On June 24, 2026, the Food and Drug Administration (FDA) published a notice of availability in the Federal Register requesting information and public comment on an Expedited Investigational New Drug (IND) pilot program. The proposed pilot program is part of the Trump administration’s focus on taking steps to strengthen America’s leadership in clinical research, accelerate the development of lifesaving treatments and ensure that patients have access to the most innovative therapies in the world.
Eye on FDA
On September 30, 2025, the Food and Drug Administration (FDA) published a Request for Public Comment to obtain feedback from interested parties on current approaches to measuring and evaluating the performance of AI-enabled medical devices. Specifically, FDA is seeking feedback on best practices, methodologies and approaches for measuring and evaluating real-world performance of AI-enabled medical devices from the public.
