OpenAI has reportedly met with officials from the U.S. Food and Drug Administration (FDA) to discuss the use of artificial ...

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

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

However, as groundbreaking as these therapies are, they also pose unique challenges for the drug development process ... accelerated development timelines, and how advanced technologies are ...

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 ...

"C-Path was built on the vision that no single entity can solve the challenges of the drug development process alone," said former C-Path CEO Dr. Woosley. "Over the last 20 years, C-Path has ...