{"id":182507,"date":"2025-11-15T19:12:19","date_gmt":"2025-11-15T19:12:19","guid":{"rendered":"https:\/\/www.europesays.com\/ie\/182507\/"},"modified":"2025-11-15T19:12:19","modified_gmt":"2025-11-15T19:12:19","slug":"fda-unveils-new-path-for-approving-drugs-for-just-one-patient","status":"publish","type":"post","link":"https:\/\/www.europesays.com\/ie\/182507\/","title":{"rendered":"FDA Unveils New Path for Approving Drugs for Just One Patient"},"content":{"rendered":"<p class=\"ArticleBodyText_articleBodyContent__17wqE typography_articleBody__3UcBa\" data-component=\"paragraph\">US regulators laid out new guidelines for approving custom-made treatments for individual patients, a move that could bring the promise of gene editing to more people with devastating diseases.<\/p>\n<p class=\"ArticleBodyText_articleBodyContent__17wqE typography_articleBody__3UcBa\" data-component=\"paragraph\">Food and Drug Administration Commissioner Marty Makary and Vinay Prasad, a top agency official, detailed their criteria for clearing personalized treatments for diseases so rare they may only affect a handful of people in an article published on Wednesday. Among other things, they want to see that a drug targets the underlying cause of the condition, like a genetic mutation, and that the patient improved after treatment.<\/p>\n","protected":false},"excerpt":{"rendered":"US regulators laid out new guidelines for approving custom-made treatments for individual patients, a move that could bring&hellip;\n","protected":false},"author":2,"featured_media":182508,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[274],"tags":[102982,1374,12008,718,18,6915,22549,3428,135,19,11995,17,102983,462,102981,11994],"class_list":{"0":"post-182507","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-medication","8":"tag-beam-therapeutics-inc","9":"tag-california","10":"tag-chief-executive-officer","11":"tag-drugs","12":"tag-eire","13":"tag-food-and-drug-administration","14":"tag-genetic-engineering","15":"tag-government","16":"tag-health","17":"tag-ie","18":"tag-industries","19":"tag-ireland","20":"tag-john-evans","21":"tag-medication","22":"tag-new-england-journal-of-medic","23":"tag-regulation"},"share_on_mastodon":{"url":"https:\/\/pubeurope.com\/@ie\/115555307173088723","error":""},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/posts\/182507","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/comments?post=182507"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/posts\/182507\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/media\/182508"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/media?parent=182507"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/categories?post=182507"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/tags?post=182507"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}