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One of the most well-attended sessions I saw at the Drug Information Association's annual conference in Philadelphia was focused on FDA efforts related to AI and real-world evidence (RWE) submissions. Three FDA officials — senior advisor on RWE Marie Bradley, associate director for AI policy Anindita Saha and digital health expert Hussein Ezzeldin — discussed recent examples of RWE used in decisionmaking and revealed a new initiative on using RWE to repurpose drug candidates for unmet medical needs. The agency also said it's now reviewed more than 1,000 AI-related submissions from
companies, with AI helping clinical trials with patient selection, outcome predictions and more. In the Q&A, industry stakeholders questioned if the the agency can provide more guidance on how companies can use AI in drug manufacturing. |
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Zachary Brennan |
Senior Editor, Endpoints News
@ZacharyBrennan
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by Zachary Brennan
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PHILADELPHIA– Following the recent departures of FDA Commissioner Marty Makary and both of his center directors for drugs and biologics, the Trump administration will... | |
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Amgen headquarters in Thousand Oaks, California (Eric Thayer/Bloomberg via Getty Images) |
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by Karen Weintraub
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Amgen has asked the FDA to review evidence that its drug Tavneos (avacopan), which treats a rare form of vasculitis, is worth keeping on the... | |
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by Max Bayer
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The FDA provided tepid support of Moderna’s flu vaccine ahead of an advisory meeting but, more importantly, didn't appear to raise any major concerns that... | |
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by Max Bayer
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The FDA gave the go-ahead for Colorado to try importing cheaper drugs from Canada, but it remains to be seen how or when this would... | |
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by Nicole DeFeudis
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CMS has proposed a policy change that clarifies its stance on how products are grouped together for Medicare negotiations. Under the Inflation Reduction Act, biologics... | |
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Worldwide made. Thanks for reading.
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