Advisory Committee
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Artificial Intelligence, BioPharma, Health Tech
FDA Forms New Digital Health Advisory Committee to Cover Growing Role of Tech
The FDA’s digital health advisory committee will discuss technologies such as artificial intelligence and machine learning, virtual reality, and digital therapeutics as well as topics like decentralized clinical trials and patient-generated health data. Committee member nominations are due in December.
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BrainStorm’s ALS Data Fail to Persuade FDA Advisors, Who Vote Down the Stem Cell Therapy
NurOwn, BrainStorm Cell Therapeutics’ experimental stem cell therapy for ALS, did not win the backing of an independent panel of FDA advisors. Many advisory committee members said they want to see more data from another clinical trial, the same guidance the FDA has given the biotech for nearly three years.
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Jorie Healthcare CEO Shares Why Automation is Critical to Revenue Cycle Management
The revenue cycle management business is using AI tools to automate cumbersome tasks to help hospitals operate more efficiently. It’s beginning to attract the attention of major healthcare organizations.
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Top Story, Daily, BioPharma, Policy
FDA often goes against advisory committee recommendations when votes are divided, study finds
Although the agency goes against about one-fifth of AdCom recommendations, a study published Sunday only found one reliable variable predicting when that would happen.
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FDA expert panel questions Daiichi Sankyo leukemia drug data ahead of meeting
A company spokesperson said the company was working to address the agency’s concerns about the drug, quizartinib, for FLT3-mutated acute myeloid leukemia.