AI In Drug Development: FDA Wants To Know How To Assure Data Integrity, Transparency, Reliability

The US Food and Drug Administration laid out the challenges that need to be addressed in using artificial intelligence and machine learning in drug development, from transparency to the quality, reliability and representativeness of data and monitoring and validation of AL/ML models.

In a discussion paper, entitled "Using Artificial Intelligence & Machine Learning in the Development of Drug & Biological Products," the agency requests input from stakeholders on their approaches and...