Day: June 13, 2024

FDA inspection or audit for Good Clinical Practices (GCP) is an important step for the FDA review of market approval applications. Although GCP audits have been conducted for more than 50 years, there has been little formal guidance from the FDA about the processes involved, leading to several anecdotes and perspectives. A new FDA guidance … Read more

This week, the FDA announced six initiatives to address various aspects of medical devices based on artificial intelligence (AI) and machine learning (ML). The programs will address major issues that should be discussed with the FDA when developing and using AI/ML technologies in medical devices.  The first initiative discusses the limitations of medical data in … Read more