Eye on FDA

On February 23, 2026, the Food and Drug Administration (FDA) released a draft guidance entitled “Considerations for the Use of the Plausible Mechanism Framework to Develop Individualized Therapies that Target Specific Genetic Conditions with Known Biological Cause.” This guidance is designed for targeted, individualized therapies for which randomized controlled trials are not practical due to a small patient population, and was previewed by the Commissioner in several public forums.

On February 1, 2026, the Food and Drug Administration (FDA) officially started accepting requests to participate in the FDA PreCheck pilot program. The goal of the program is to strengthen the domestic pharmaceutical supply chain by making the review and inspection process more predictable for U.S.-based drug manufacturing facilities.

The Food and Drug Administration (FDA) has begun 2026 with a clear signal to the direct‑to‑consumer testing industry: self‑collection devices remain firmly within the agency’s regulatory reach, notwithstanding the 2025 court ruling on laboratory developed tests (LDTs). Last week, the agency published warning letters previously issued to four companies—Genetrace, Genovate, Germaphobix and ProDx Health—selling human immunodeficiency virus (HIV) tests that rely on unauthorized self‑collection kits.

On January 6, the Food and Drug Administration (FDA) updated its guidance documents on Clinical Decision Support (CDS) software and general wellness products, and withdrew its guidance on the adoption of international principles for Software as a Medical Device (SaMD): Clinical Evaluation. FDA’s policy changes lean toward a more deregulatory approach to digital health, including enforcement discretion for certain prediction software, and exemption of certain wearables with non-invasive monitoring from FDA regulation.

On December 18, 2025, the Food and Drug Administration (FDA) released a final guidance entitled “Processes and Practices Applicable to Bioresearch Monitoring Inspections.” The guidance was issued to comply with the Food and Drug Omnibus Reform Act of 2022, which directs FDA to issue guidance describing the processes and practices applicable to inspections of sites and facilities inspected under FDA’s Bioresearch Monitoring (BIMO) inspection program, to the extent that is not covered in already available FDA guides and manuals. The BIMO program was established to assess and monitor the conduct and reporting of FDA-regulated research as well as postmarketing activities through on-site inspections, investigations and Remote Regulatory Assessments.

On December 5, 2025, FDA announced its Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot, a new voluntary pilot that seeks to accelerate innovation and expand access to digital health devices for people living with chronic conditions. Under TEMPO, FDA will evaluate a new, risk-based enforcement approach that supports digital health devices intended for use to improve patient outcomes in cardio-kidney-metabolic, musculoskeletal and behavioral health conditions. Under the pilot, participating manufacturers may request that the agency exercise enforcement discretion for certain requirements, such as premarket authorization and investigational device requirements, while manufacturers collect and share real-world data demonstrating the device’s performance.

Last week, FDA released draft guidance titled “Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies.” This draft guidance reflects an evolution in FDA’s approach to determining whether a comparative clinical study with efficacy endpoints (a comparative efficacy study or CES) is necessary to support a demonstration of biosimilarity. Specifically, the agency notes that a comparative analytical assessment (CAA) is generally more sensitive when it comes to detecting differences between products than a CES.

The White House’s Make America Healthy Again (MAHA) Commission, led by the Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr., released its highly anticipated strategy outlining a multi-agency approach focused on addressing childhood chronic disease. The strategy builds on the Commission’s inaugural health assessment, a report which examined the rising rates of childhood chronic diseases in the country and identified four primary drivers: poor diet due to consumption of ultra-processed foods (UPFs), exposure to environmental chemicals; increased technological use; and overmedicalization. To combat these challenges, the strategy released on September 9, 2025, outlines a four-prong approach which provides further insight into the areas the administration sees as key areas of MAHA going forward: advancing research, realigning incentives, increasing public awareness and fostering private sector collaborations.

This morning, the U.S. Food and Drug Administration (FDA) announced the publication of more than 200 decision letters, also known as complete response letters (CRLs), with plans to release more from the archives. The CRLs released today are associated with applications for drugs and biologics submitted for approval between 2020 and 2024 that have since been approved by the agency.