FDA’s CDER Is Fostering Use Of Artificial Intelligence In Drug Development
Center for Drug Evaluation and Research plans to issue a request for information this year to engage stakeholders on issues related to AI and machine learning. It received 175 AI/ML submissions in 2022, up from 14 in 2020.
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Barrier For Applying AI To Precision Medicine: Drug Industry Reluctance To Share Data
Eric Topol says there is not enough regulatory teeth to require companies to share data with the medical community. Experts at a workshop on the application of artificial intelligence and machine learning for precision medicine also want data and algorithms to be accessible.
US FDA’s OPQ Aims To Clear The Way For Further Manufacturing Technology Advances in 2023
As the agency's Office of Pharmaceutical Quality releases its annual report highlighting last year's efforts to advance distributed and point-of-care manufacturing, OPQ director Kopcha tells the Pink Sheet of plans to focus on activities advancing the use of artificial intelligence in manufacturing process control this year.
Artificial Intelligence Is Future Of Postmarketing Surveillance, US FDA’s Marks Says
CBER director’s vision for a national safety surveillance system includes use of AI and natural language processing to enable near-real time signal detection from adverse event reports.