Commissioner Markary announced the plans alongside the results of a generative AI pilot for scientific reviewers.

The U.S. Centers for Medicare and Medicaid Services (CMS) said on Monday that it would announce a list of 15 drugs eligible ...

Qualification program creates a pathway to evaluate Clinical Outcome Assessments (COAs) that capture a specific concept of interest (COI) in a specified Context of Use (COU). If successfully qualified ...

High-ranking OpenAI employees have met with the FDA multiple times in recent weeks to discuss AI and a project called cderGPT ...