Recent FDA actions offer long-awaited clarity on what constitutes a ‘minor change’ to solid oral OTC dosage forms, providing manufacturers with a clearer pathway for certain modifications while maintaining a measured, incremental approach to innovation. The FDA docket is open until October 3 for comments.
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YOUR GO-TO SOURCE FOR ANALYSIS OF ISSUES AFFECTING THE PHARMA & BIOTECH SECTORS
The US Department of Justice’s settlement with Illumina, Inc. is a first-of-its-kind involving alleged cybersecurity deficiencies causing violations of the False Claims Act (FCA) based on FDA quality standards. The cybersecurity framework, typically seen in other industries such as defense contracting, serves as a warning to companies in the life sciences, medtech, and digital health space that DOJ and the whistleblower bar are expanding the scope of this flavor of FCA enforcement and should prepare accordingly.
FDA’s New Priority Voucher Program for Drug Developers Ties Incentives to Defined National Interests
The US Food and Drug Administration recently announced the launch of a regulatory incentive pilot program, the Commissioner’s National Priority Voucher Program (CNPVP), designed to reward drug and biologic sponsors that align their development activities with specific US national interests.
The One Big Beautiful Bill Act takes a big step in the rare disease space by expanding the contours of the orphan drug exclusion, a once narrow exception that permitted manufacturers of rare disease drugs and biologics to be insulated from consideration in Medicare drug price negotiations. By redefining the qualifications for negotiation eligibility, the bill hopes to create opportunity for renewed innovation for orphan drug products.
The US Food and Drug Administration has announced a renewed focus on a long-considered issue—whether FDA should release complete response letters (CRLs) issued to drug or biologic applicants. Specifically, on July 10, 2025 FDA compiled and released more than 200 CRLs issued between 2020 and 2024 for approved new drug application (NDA) and biologics license application (BLA) products. Improving on past agency practice, these CRLs are now located within a single database, providing the public with easy access to a trove of information regarding FDA’s thinking when making approval decisions.
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.
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.
While the US Food and Drug Administration has been experiencing recent reorganization and cuts in personnel, the United Kingdom has its own upcoming policy changes making it easier and faster to initiate and maintain UK clinical trials, which will create attractive new options and strategy decisions for pharma research and development companies.
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.”