Eye on FDA

On February 3, 2026, the Consolidated Appropriations Act, 2026 (P.L. 119-75) became law and marked an important milestone in the bipartisan congressional effort to reauthorize the rare pediatric disease priority review voucher program. Section 6604 of this law extends the Food and Drug Administration’s (FDA) authority to issue priority review vouchers to encourage treatments for rare pediatric diseases through September 30, 2029.

In case you missed it, Department of Health and Human Services Secretary Robert F. Kennedy Jr. and former Food and Drug Administration (FDA) Commissioner David Kessler appeared on 60 Minutes this past Saturday, February 15, in a segment titled “Generally Recognized as Safe.” As the title suggests, the conversation centered on FDA’s Generally Recognized as Safe (GRAS) regulatory pathway (for background, see our prior post discussing in more detail the GRAS process), as well as Commissioner Kessler’s August 2025 citizen petition urging FDA to revoke the GRAS status of refined carbohydrates used in industrial food processing (discussed in more detail in our earlier coverage of the petition).

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.

On October 23, 2025, FDA released its final guidance regarding Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments. The guidance is the third guidance in a four-part series of FDA guidance focused on patient-focused drug development (PFDD) that describe how stakeholders, such as patients, caregivers, researchers, medical product developers and others can submit patient experience data and other relevant information that can be used for medical product development and regulatory decision making.