{"id":706,"date":"2025-05-11T10:00:40","date_gmt":"2025-05-11T10:00:40","guid":{"rendered":"https:\/\/musictechohio.online\/site\/fda-ai-approve-drugs\/"},"modified":"2025-05-11T10:00:40","modified_gmt":"2025-05-11T10:00:40","slug":"fda-ai-approve-drugs","status":"publish","type":"post","link":"https:\/\/musictechohio.online\/site\/fda-ai-approve-drugs\/","title":{"rendered":"The FDA Will Use AI to Accelerate Approving Drugs"},"content":{"rendered":"<div>\n<div><img loading=\"lazy\" width=\"2400\" height=\"1260\" src=\"https:\/\/wordpress-assets.futurism.com\/2025\/05\/fda-ai-approve-drugs.png\" class=\"attachment-full size-full wp-post-image\" alt=\"The FDA announced that it will start using AI across all of its centers to shorten the drug review process.\" style=\"margin-bottom: 15px;\" decoding=\"async\"><\/div>\n<p><span style=\"font-weight: 400;\">The Food and Drug Administration just <\/span><a href=\"https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-announces-completion-first-ai-assisted-scientific-review-pilot-and-aggressive-agency-wide-ai\"><span style=\"font-weight: 400;\">announced<\/span><\/a><span style=\"font-weight: 400;\"> that it will immediately start using AI across all of its centers, after completing a new generative AI pilot for scientific reviewers.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Supposedly, the AI tool will speed up the FDA&#8217;s drug review process by reducing the time its scientists have to spend doing tedious, repetitive tasks \u2014 though, given AI&#8217;s <a href=\"https:\/\/futurism.com\/the-byte\/openai-new-ai-problem-hallucinate-more\">track record of constantly hallucinating<\/a>, these claims warrant plenty of scrutiny.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">&#8220;This is a game-changer technology that has enabled me to perform scientific review tasks in minutes that used to take three days,&#8221; said Jinzhong Liu, a deputy director in the FDA&#8217;s Center for Drug Evaluation and Research (CDER), in a statement.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">FDA commissioner Martin Makary has directed that all FDA centers should achieve full AI integration by June 30, a questionably aggressive timeline.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">&#8220;By that date, all centers will be operating on a common, secure generative AI system integrated with FDA&#8217;s internal data platforms,&#8221; the agency said in its announcement.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The announcement comes just a day after <\/span><a href=\"https:\/\/www.wired.com\/story\/openai-fda-doge-ai-drug-evaluation\/\"><i><span style=\"font-weight: 400;\">Wired <\/span><\/i><span style=\"font-weight: 400;\">reported<\/span><\/a><span style=\"font-weight: 400;\"> that the FDA and OpenAI were holding talks to discuss the agency&#8217;s use of AI. Notably, the FDA&#8217;s new statement makes no mention of OpenAI or its potential involvement.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Behind the scenes, however, <\/span><i><span style=\"font-weight: 400;\">Wired <\/span><\/i><span style=\"font-weight: 400;\">sources say that a team from the ChatGPT maker met with the FDA and two associates from Elon Musk&#8217;s so-called Department of Government Efficiency multiple times in recent weeks, to discuss a project called &#8220;cderGPT.&#8221; The name is almost certainly a reference to the FDA&#8217;s abovementioned CDER, which regulates drugs sold in the US.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">This may have been a long time coming. <\/span><i><span style=\"font-weight: 400;\">Wired <\/span><\/i><span style=\"font-weight: 400;\">notes that the <\/span><a href=\"https:\/\/www.zintellect.com\/Opportunity\/Details\/FDA-CDER-2023-1326\"><span style=\"font-weight: 400;\">FDA sponsored a fellowship<\/span><\/a><span style=\"font-weight: 400;\"> in 2023 to develop large language models for internal use. And according to Robert Califf, who served as FDA commissioner between 2016 and 2017, the agency review teams have already been experimenting with AI for several years.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">&#8220;It will be interesting to hear the details of which parts of the review were &#8216;AI assisted&#8217; and what that means,&#8221; Califf told <\/span><i><span style=\"font-weight: 400;\">Wired<\/span><\/i><span style=\"font-weight: 400;\">. &#8220;There has always been a quest to shorten review times and a broad consensus that AI could help.&#8221;<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The agency was considering using AI in other aspects of its operations, too. <\/span><\/p>\n<p><span style=\"font-weight: 400;\">&#8220;Final reviews for approval are only one part of a much larger opportunity,&#8221; Califf added.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Makary, who was appointed commissioner by president Donald Trump, has frequently expressed his enthusiasm for the technology. <\/span><\/p>\n<p><span style=\"font-weight: 400;\">&#8220;Why does it take over ten years for a new drug to come to market?&#8221; he <a href=\"https:\/\/x.com\/drmakaryfda\/status\/1920151300429185233\">tweeted<\/a> on Wednesday<\/span><span style=\"font-weight: 400;\">. &#8220;Why are we not modernized with AI and other things?&#8221;<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The FDA news parallels a broader trend of AI adoption in federal agencies during the Trump administration. In March, OpenAI announced a version of its chatbot called <\/span><a href=\"https:\/\/futurism.com\/trump-openai-chatgpt-gov\"><span style=\"font-weight: 400;\">ChatGPT Gov<\/span><\/a><span style=\"font-weight: 400;\"> designed to be secure enough to process sensitive government information. Musk has <\/span><a href=\"https:\/\/www.wired.com\/story\/doge-chatbot-ai-first-agenda\/\"><span style=\"font-weight: 400;\">pushed to fast-track<\/span><\/a><span style=\"font-weight: 400;\"> the development of another AI chatbot for the US General Services Administration, while using the technology to <\/span><a href=\"https:\/\/futurism.com\/elon-musk-rewriting-social-security-code-ai\"><span style=\"font-weight: 400;\">try to rewrite the Social Security computer system<\/span><\/a><span style=\"font-weight: 400;\">.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Yet, the risks of using the technology in a medical context are <a href=\"https:\/\/futurism.com\/neoscope\/medical-ai-doctor-lies-records\">concerning<\/a>, to say the least. Speaking to <\/span><i><span style=\"font-weight: 400;\">Wired<\/span><\/i><span style=\"font-weight: 400;\">, an ex-FDA staffer who has tested ChatGPT as a clinical tool pointed out the chatbot&#8217;s proclivity for <\/span><a href=\"https:\/\/futurism.com\/sophisticated-ai-likely-lie\"><span style=\"font-weight: 400;\">making up convincing-sounding lies<\/span><\/a><span style=\"font-weight: 400;\"> \u2014 a problem that <\/span><a href=\"https:\/\/futurism.com\/ai-industry-problem-smarter-hallucinating\"><span style=\"font-weight: 400;\">won&#8217;t go away anytime soon<\/span><\/a><span style=\"font-weight: 400;\">.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">&#8220;Who knows how robust the platform will be for these reviewers&#8217; tasks,&#8221; the former FDA employee told the magazine.<\/span><\/p>\n<p><strong>More on medical AI: <\/strong><em><a href=\"https:\/\/futurism.com\/nonverbal-neuralink-patient-grok-answers\">Nonverbal Neuralink Patient Is Using Brain Implant and Grok to Generate Replies<\/a><\/em><\/p>\n<p>The post <a href=\"https:\/\/futurism.com\/fda-ai-approve-drugs\">The FDA Will Use AI to Accelerate Approving Drugs<\/a> appeared first on <a href=\"https:\/\/futurism.com\/\">Futurism<\/a>.<\/p>\n<\/div>\n<div style=\"margin-top: 0px; margin-bottom: 0px;\" class=\"sharethis-inline-share-buttons\" ><\/div>","protected":false},"excerpt":{"rendered":"<p>The Food and Drug Administration just announced that it will immediately start using AI across all of its centers, after completing a new generative AI pilot for scientific reviewers. Supposedly,&hellip;<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[177,319,320,179,321],"tags":[],"class_list":["post-706","post","type-post","status-publish","format-standard","hentry","category-artificial-intelligence","category-fda","category-medical-ai","category-openai","category-trump"],"_links":{"self":[{"href":"https:\/\/musictechohio.online\/site\/wp-json\/wp\/v2\/posts\/706","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/musictechohio.online\/site\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/musictechohio.online\/site\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/musictechohio.online\/site\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/musictechohio.online\/site\/wp-json\/wp\/v2\/comments?post=706"}],"version-history":[{"count":0,"href":"https:\/\/musictechohio.online\/site\/wp-json\/wp\/v2\/posts\/706\/revisions"}],"wp:attachment":[{"href":"https:\/\/musictechohio.online\/site\/wp-json\/wp\/v2\/media?parent=706"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/musictechohio.online\/site\/wp-json\/wp\/v2\/categories?post=706"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/musictechohio.online\/site\/wp-json\/wp\/v2\/tags?post=706"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}