FDA's New Communications and Compliance Tool for Device Data Integrity Concerns

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.

On June 2, 2026, the U.S. Food and Drug Administration (FDA) issued draft guidance on how drug and device companies may communicate health care economic information (HCEI) with payors (e.g., health insurance companies), formulary committees (e.g., pharmacy and therapeutics committees) and similar entities. The guidance, Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers, is now open for comment.

On May 12, 2026, the Food and Drug Administration (FDA) published a notice in the Federal Register requesting comment on the agency’s efforts related to drug repurposing to help address unmet medical needs. In this request for information (RFI), FDA is seeking input to identify potential new uses for FDA-approved drugs—such as a new indication or a new population—to help accelerate the availability of treatments for unmet medical needs. Stakeholders are encouraged to submit priority disease areas and potential candidates for drug repurposing, particularly in cases where there is a lack of commercial incentive to pursue labeling changes or a significant unmet need.

As medical chatbots proliferate, a new Pennsylvania lawsuit highlights a developing trend of states leading health artificial intelligence (AI) enforcement efforts, while the Food and Drug Administration (FDA) appears to be on the sidelines.