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 ...

FDA Commissioner Marty Makary’s proposal to roll out a new drug approval pathway is heightening hope for the rare disease ...

THE new Food and Drug Administration (FDA) application procedures are expected to reduce the drug permit process by as much as half ... “We need to build factories … because our research and ...

Biotech companies developing drugs for hard-to-treat diseases and other ailments are being forced to push back clinical trials and drug testing in the wake of mass layoffs at the Food and Drug ...

One area where AI’s impact is already on display is within the clinical trial process, where its use ... the way for novel methodologies in drug development. The dynamic interplay between ...

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

While China’s regulatory process doesn’t uphold the patient safeguards that Americans rightly insist upon, the U.S. FDA could still streamline its path into early-stage drug development ...

Clinical trials are vital to drug development but often face challenges ... are transforming this process by optimizing trial protocols, enhancing recruitment, and accelerating timelines.

WASHINGTON-The US Food and Drug Administration (FDA) said on April 10 it plans to replace animal testing in the development of monoclonal antibody therapies and other drugs with “human-relevant ...