FDA Release of Complete Response Letters Raises Confidentiality, Disclosure Questions But Offers Insights for Development
On July 10, 2025 — in a move it characterized as “radical transparency” — the U.S. Food and Drug Administration (FDA or Agency) published over 200 Complete Response Letters (CRLs), which are issued when the Agency determines that it will not approve a New Drug Application (NDA) or Biologics License Application (BLA). We analyze the implications of this development for life sciences companies and their investors.
New U.S. FDA Draft Guidance Outlines Path To Faster Modification of AI/ML-Enabled Devices
The U.S. Food and Drug Administration (FDA or Agency) has issued new draft guidance on “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions”1 that discusses a “science-based approach to ensuring that AI/ML-enabled devices can be safely, effectively, and rapidly modified, updated, and improved in response to new data.”2 This approach should offer more certainty to industry as FDA’s stated goal is to allow AI/ML-enabled devices to be modified faster in accordance with FDA requirements while being “built to adapt to the data and needs of individual health care facilities” and “adapt to deliver treatments according to individual users’ particular characteristics and needs.”3 Those wishing to comment on the draft guidance should note that the comment period closes on July 3, 2023.
One Step Forward, Two Steps Back: FDA’s Final Guidance on Clinical Decision Software Raises More Questions Than Answers
Recently, the U.S. Food and Drug Administration (FDA) published a suite of guidance documents relating to software, automation, and artificial intelligence. One guidance document in particular, addressing clinical decision support (CDS) software, may signal a tightening in FDA’s oversight on software tools with artificial intelligence and machine learning (AI/ML) that could introduce confusion and frustrate innovation in this important, fast-developing area. On October 18, 2022, FDA held a webinar to provide additional clarifications on this final guidance.
