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Artificial Intelligence Is Future Of Postmarketing Surveillance, US FDA’s Marks Says

 
• By Sue Sutter

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.

FDA circuit board
FDA has had to bridge gaps in access to postmarketing surveillance data for COVID-19 vaccines. • Source: Nielsen Hobbs; the Pink Sheet | Shutterstock image

The US Food and Drug Administration wants to use artificial intelligence and natural language processing to improve its postmarketing safety oversight of biologics and vaccines, Center for Biologics Evaluation and Research director Peter Marks said on 10 May.

Speaking to the Alliance for a Stronger FDA about the agency’s fiscal year 2023 budget request, the CBER director said one of his long-term goals, funding permitting, is advancing its safety surveillance systems to make them more efficient and effective in picking up

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