A new procedural document issued by the US Food and Drug Administration (FDA) instructs its staff on the best practices-known as Good Review Practices (GVPs)-used in the review of investigational new ...
The process of discovering new drugs and bringing them to market is notoriously slow and inefficient. Amazon Web Services is hoping to use AI to streamline this process, it announced Tuesday. Amazon ...
In July 2025, the US Food and Drug Administration (FDA) announced a pilot program intended to expedite reviews for drug applications that met one of five national priorities, including products deemed ...
A commentary by FDA officials Vinay Prasad, MD, MPH, and Martin Makary, MD, MPH, details the new system for drug approvals in the US. FDA Commissioner Martin Makary, MD, MPH, and his top deputy Vinay ...