Eye on FDA

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.

On May 12, 2026, the U.S. Food and Drug Administration (FDA) announced a major milestone in its approach to post-market oversight of chemicals in the food supply, finalizing a new proactive food chemical safety post-market assessment program and releasing two foundational papers: the “Enhanced Systematic Process for Post-Market Assessment of Chemicals in Food” and the “Tool for the Prioritization of Food Chemicals for Post-Market Assessment.”

In December 2016, the bipartisan 21st Century Cures Act (P.L. 114-255) was enacted, marking a pivotal milestone in advancing a patient-focused drug development (PFDD) paradigm. This law directed the Food and Drug Administration (FDA) to develop and implement strategies to solicit view of patients during the medical product development process and consider the perspectives of patients during regulatory discussions. Over the past decade, FDA has steadily taken steps to implement the 21st Century Cures Act patient-focused drug development provisions, including through meetings by which patients, caregivers, family members and patient advocates, among others, have been able to provide information about patients’ experiences with a disease or condition. The opportunity to provide such feedback through these patient-focused meetings is a key pillar of the agency’s patient-focused drug development engagement.

On April 28, 2026, the Food and Drug Administration (FDA) unveiled two major announcements as part of its initiative to “advance the implementation of real-time clinical trials.” In conjunction with a request for information (RFI) for a proposed pilot program, the agency announced the successful initiation of two proof-of-concept real-time clinical trials (RTCTs). Taken together, the agency’s stated goal is to enable continuous trials and reduce the “hiatuses” between the phases of clinical development, ultimately improving the drug development process.

On March 31, 2026, the Food and Drug Administration (FDA) published a notice in the Federal Register requesting information and public comment (RFI) on the use of digital health technologies (DHTs) in clinical investigations for drugs and biological products. To inform potential FDA activities in this area, the Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) are seeking feedback to better understand the opportunities and challenges associated with using these innovative technologies in clinical investigations.

On March 30, 2026, the Food and Drug Administration (FDA) published a final guidance entitled “Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle.” The guidance provides updated recommendations to industry and FDA on how and when voluntary patient preference information (PPI) may be considered by FDA staff in decision making relating to devices. PPI is not required for FDA’s consideration as part of FDA decision making, but FDA may find it valuable to consider patient viewpoints when the information meets applicable legal requirements. In addition, FDA encourages industry and other interested parties to consider patient experience data in device development and evaluation, including data relating to patient preferences for outcomes and treatments. FDA acknowledges that patient perspective and personal experiences can help FDA evaluate the benefit-risk profile of certain devices throughout the total product life cycle.

On March 20, 2026, the Food and Drug Administration (FDA) announced the agency will hold a public hearing on the Commissioner’s National Priority Voucher (CNPV) Pilot Program, with a Federal Register notice soliciting public comment and scheduling a public hearing for June 12, 2026. As previously noted here and here, the program was announced in June 2025 for the purpose of providing select sponsors with a nontransferable voucher for enhanced engagement with FDA and expedited review for drugs and biologics supporting one or more critical national health priorities, while maintaining adherence to the law’s rigorous safety and effectiveness standards. The national health priorities include public health crisis response, innovative breakthrough therapies, large unmet medical needs, onshoring and supply chain resilience initiatives, and affordability improvements. To date, FDA has issued 18 Commissioner’s National Priority vouchers and approved four products to receive these vouchers, including two oncology drugs 44 and 55 days after filing.

On March 18, 2026, the Food and Drug Administration (FDA) issued draft guidance entitled “General Considerations for the Use of New Approach Methodologies in Drug Development.” The guidance is meant to provide drug developers with a validation framework and general recommendations for using new approach methodologies (NAMs) in drug development. The use of NAMs can improve predictive toxicology in humans and reduce reliance on animal testing.