As Prescribed

Ariel Seeley served on the panel titled AI Trends in Medical Devices: Global Developments, FDA Policies, and Software as a Medical Device at the 2025 Food and Drug Law Institute (FDLI) Annual Conference. The panel provided an overview of FDA’s approach to predetermined change control plans (PCCPs) and its draft guidance on pre-market submission requirements for AI-enabled devices, a summary of current trends in devices enabled with artificial intelligence (AI) or authorized with PCCPs, as well as the burgeoning global adoption of PCCPs.

Guidance development and publication from the Food and Drug Administration (FDA) has long been considered an essential element of medical product development, approval, and regulation. While temporary pauses in guidance publication are a frequent side effect of changes in administration, after the January 2025 executive order (EO) announcing a “10-to-1” deregulatory policy, many have wondered what guidance development and publication might look like going forward. Drawing from multiple corners of FDA, recent actions from the agency may begin to paint a picture for us, showing a mix of traditional and novel approaches.

FDA’s recent focus on potentially harmful color additives in food products has expanded to the pharmaceutical sector. In May 2025, FDA issued a draft guidance titled Replacing Color Additives in Approved or Marketed Drug Products. This guidance signals FDA’s increasing attention to the use of colors in all consumable products, including both prescription and over-the-counter (OTC) drugs.

On June 2, 2025, FDA announced the launch of Elsa, a generative AI tool designed to “help employees—from scientific reviewers to investigators—work more efficiently.” Per FDA, the tool “modernizes agency functions and leverages AI capabilities to better serve the American people.” While Elsa may add efficiencies to FDA’s review processes, it also raises a number of questions for regulated industry.

Distributors, dispensers, and retailers of medical device products face a patchwork of federal and state requirements governing distribution chain compliance. Given the evolving and expanding requirements for device distribution activities, companies must take proactive measures to assess and mitigate risk. Below are key considerations that companies operating in this space should consider to safeguard their operations and maintain compliance.

Drug approval is unequivocally the linchpin to any drug development effort and, given the role of the US market in the global marketplace, the drug approval standard employed by FDA remains a perennial focus of stakeholders across the industry. In light of recent remarks from the FDA commissioner on the development of a new conditional approval pathway, we revisit FDA’s existing approval standard and the broader regulatory and policy context that has, to date, underpinned FDA’s drug approval practices and anchored the agency as the worldwide “gold standard.”

The US Food and Drug Administration (FDA) recently announced a strategic roadmap to phase out animal testing requirements for certain drug products, starting with monoclonal antibodies. This shift marks a significant change in regulatory policy, reflecting advancements in science and technology that offer alternative testing methods.

The US Food and Drug Administration (FDA) recently published two new draft guidances to implement provisions of the Food and Drug Omnibus Reform Act (FDORA) aimed at refining the accelerated approval pathway. These guidances seek to address regulatory challenges and enhance oversight of drug products granted accelerated approval. Additionally, a recent report from the Office of the Inspector General (OIG) underscores FDA’s efforts in refining the accelerated approval pathway. These efforts raise important implications for the rare disease community.

The value of merger and acquisition (M&A) deals of rare disease companies has increased significantly over the past few years (from $18.9 billion in 2019 to $50.6 billion in 2022 according to a 2024 article in Nature Reviews Drug Discovery). This combined with recent billion-dollar acquisitions in the rare disease space have piqued the interest of large pharmaceutical companies, as well as investors, and may be indicative of further growth of this life sciences sector in the years ahead. This article analyses some of the key challenges faced by parties to an M&A transaction in the rare disease space and outlines strategies that can be deployed to ensure a successful closing.

In response to calls from industry stakeholders for increased innovation, coordination, and tailored regulatory approaches to the development of treatments in rare disease, in recent years the US Food and Drug Administration (FDA) has established a number of rare disease-focused programs within the agency. Building on other recent FDA initiatives such as the Center for Drug Evaluation and Research (CDER) Accelerating Rare disease Cures (ARC) Program and the Center for Biologic Evaluation and Research (CBER) Rare Disease Program, FDA expanded its rare disease toolkit to include its Rare Disease Innovation Hub in 2024 to serve as a point of collaboration between CDER and CBER with the overarching goal of enhancing collaboration across centers to improve patient outcomes and addressing common challenges in drug development for rare diseases.