{"id":139261,"date":"2025-11-14T10:29:09","date_gmt":"2025-11-14T10:29:09","guid":{"rendered":"https:\/\/www.newsbeep.com\/ie\/139261\/"},"modified":"2025-11-14T10:29:09","modified_gmt":"2025-11-14T10:29:09","slug":"fda-unveils-new-path-for-approving-drugs-for-just-one-patient","status":"publish","type":"post","link":"https:\/\/www.newsbeep.com\/ie\/139261\/","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":139262,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[33],"tags":[80260,811,15704,424,14850,16312,1523,103,61,15706,60,80261,371,80259,4269],"class_list":["post-139261","post","type-post","status-publish","format-standard","has-post-thumbnail","category-medication","tag-beam-therapeutics-inc","tag-california","tag-chief-executive-officer","tag-drugs","tag-food-and-drug-administration","tag-genetic-engineering","tag-government","tag-health","tag-ie","tag-industries","tag-ireland","tag-john-evans","tag-medication","tag-new-england-journal-of-medic","tag-regulation"],"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/posts\/139261","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/comments?post=139261"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/posts\/139261\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/media\/139262"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/media?parent=139261"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/categories?post=139261"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/tags?post=139261"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}