Lexology May 11, 2023
On Wednesday, May 10, 2023, the Food and Drug Administration (FDA) announced the publication of a new discussion paper titled “Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products.”The discussion paper aims to facilitate a discussion with stakeholders on the use of artificial intelligence and machine learning (AI/ML) in drug development, including the development of medical devices intended for use with drugs.The discussion paper covers three main topics: the landscape of current and potential uses of AI/ML; considerations for the use of AI/ML; and next steps and stakeholder engagement.
Here are five key takeaways:
1.FDA Acknowledges that AI/ML Applications Exist for Each Stage of Drug Development. AI/ML may have applications for use in all stages...
Today's Sponsors
Today's Sponsor