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 ...

While significant progress has been made in developing treatments for rare diseases—highlighted by the approval of over 800 drugs for orphan diseases since ...

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 ...