FDA Puts Orange B on the Chopping Block

Last week, FDA released draft guidance titled “Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative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 This draft guidance reflects an evolution in FDA’s approach to determining whether a comparative clinical study with efficacy endpoints (a comparative efficacy study or CES) is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.

On October 16, 2025, the Food and Drug Administration (FDA) unveiled the first group of nine voucher recipients under the Commissioner’s National Priority Voucher (CNPV) pilot program, a program announced by the agency earlier this year that provides a path for accelerated drug review for companies supporting national interests as determined by the Commissioner. The identified areas of priority by the agency include meeting large unmet medical needs, bolstering domestic manufacturing and increasing the affordability of medicines for American patients. As previously noted, the new program, which is not defined in statute or regulations, aims to significantly speed up FDA’s standard 10-12 month review timeline to just 1-2 months after filing an application for a drug or biologic. The agency has touted the  benefit of recipients of the vouchers receiving enhanced access with FDA review staff and a “team-based review” model.

On September 30, 2025, the Food and Drug Administration (FDA) published a Request for Public Comment to obtain feedback from interested parties on current approaches to measuring and evaluating the performance of AI-enabled medical devices. Specifically, FDA is seeking feedback on best practices, methodologies and approaches for measuring and evaluating real-world performance of AI-enabled medical devices from the public.