FDA Releases Draft Guidance on AI in Drug Development
Brief news summary
After almost ten years of advancements in machine learning within the pharmaceutical industry, the FDA has released its first draft guidance on incorporating artificial intelligence in the development of drugs and biological products. This guidance is timely, as drug regulatory submissions involving AI have surged dramatically. Since 2016, the agency has received over 500 drug submissions featuring AI components, notably in fields such as oncology, neurology, and gastroenterology. Tala Fakhouri, co-leader of the FDA's Center for Drug Evaluation and Research’s AI Council, highlighted this trend during an interview with STAT.After almost ten years of machine learning advancements in the pharmaceutical sector, the Food and Drug Administration released its initial draft guidance on using artificial intelligence for drug and biological product development on Monday. This guidance emerges as there has been a significant rise in drug regulatory submissions incorporating AI.
In a STAT interview in October, Tala Fakhouri from the FDA, a co-leader of the Center for Drug Evaluation and Research’s AI Council, stated that the agency has received over 500 drug submissions involving AI since 2016, particularly in the fields of oncology, neurology, and gastroenterology.
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FDA Releases Draft Guidance on AI in Drug Development
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