FDA Releases Two Discussion Papers to Spur Conversation about Artificial Intelligence and Machine Learning in Drug Development and Manufacturing.

The regulatory uses are real: In 2021, more than 100 <a target=" blank" xlink:href="https://ascpt.onlinelibrary.wiley.com/doi/10.1002/cpt.2668">drug and biologic applications</a> submitted to the FDA included AI/ML components. Keywords: Algorithms; Artificial Intelligence; Bioengineering; Biologics; Biotechnology; Cybersecurity; Cyborgs; Drug Development; Drug Manufacturing; Drugs and Therapies; Emerging Technologies; FDA; Genetic Engineering; Genetically-Engineered Proteins; Government Agencies Offices and Entities; Health and Medicine; Machine Learning; Office of the FDA Commissioner; Public Health; Technology; U.S. Food and Drug Administration EN Algorithms Artificial Intelligence Bioengineering Biologics Biotechnology Cybersecurity Cyborgs Drug Development Drug Manufacturing Drugs and Therapies Emerging Technologies FDA Genetic Engineering Genetically-Engineered Proteins Government Agencies Offices and Entities Health and Medicine Machine Learning Office of the FDA Commissioner Public Health Technology U.S. Food and Drug Administration 497 497 1 05/22/23 20230523 NES 230523 2023 MAY 22 (NewsRx) -- By a News Reporter-Staff News Editor at Clinical Trials Week -- By: Patrizia Cavazzoni, M.D., Director of the Center for Drug Evaluation and Research Artificial intelligence (AI) and machine learning (ML) are no longer futuristic concepts; they are now part of how we live and work. [Extracted from the article]