{"id":478,"date":"2025-01-28T10:38:57","date_gmt":"2025-01-28T14:38:57","guid":{"rendered":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/?p=478"},"modified":"2025-01-28T10:38:58","modified_gmt":"2025-01-28T14:38:58","slug":"fda-issues-draft-guidance-qa-on-developing-potential-cellular-and-gene-therapy-products","status":"publish","type":"post","link":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/2025\/01\/28\/fda-issues-draft-guidance-qa-on-developing-potential-cellular-and-gene-therapy-products\/","title":{"rendered":"FDA Issues Draft Guidance Q&amp;A on Developing Potential Cellular and Gene Therapy Products"},"content":{"rendered":"\n<p>In November 2024, the U.S. Food and Drug Administration (FDA) issued\u00a0<a href=\"https:\/\/www.fda.gov\/media\/183631\/download\" target=\"_blank\" rel=\"noreferrer noopener\">draft Guidance<\/a>\u00a0responding to frequently asked questions about developing cellular and gene therapy (CGT) products. This draft Guidance supplements existing finalized and draft\u00a0<a href=\"https:\/\/www.fda.gov\/vaccines-blood-biologics\/biologics-guidances\/cellular-gene-therapy-guidances\" target=\"_blank\" rel=\"noreferrer noopener\">Guidance<\/a>\u00a0on CGT products.<\/p>\n\n\n\n<p>Read the full <em>Alert<\/em> on the <a href=\"https:\/\/www.duanemorris.com\/alerts\/fda_draft_guidance_q&amp;a_developing_potential_cellular_gene_therapy_products_0125.html\">Duane Morris LLP Website<\/a>.<\/p>\n\n\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>In November 2024, the U.S. Food and Drug Administration (FDA) issued\u00a0draft Guidance\u00a0responding to frequently asked questions about developing cellular and gene therapy (CGT) products. This draft Guidance supplements existing finalized and draft\u00a0Guidance\u00a0on CGT products. Read the full Alert on the Duane Morris LLP Website.<\/p>\n","protected":false},"author":6,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[2],"tags":[],"ppma_author":[521],"class_list":["post-478","post","type-post","status-publish","format-standard","hentry","category-general"],"authors":[{"term_id":521,"user_id":6,"is_guest":0,"slug":"duanemorris3","display_name":"Duane Morris","avatar_url":"https:\/\/secure.gravatar.com\/avatar\/843ff6e7a8fe5fc92109b47a45f34b6cf0ea499e6e788db23456c838b0ae6747?s=96&d=blank&r=g","0":null,"1":"","2":"","3":"","4":"","5":"","6":"","7":"","8":""}],"_links":{"self":[{"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/posts\/478","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/users\/6"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/comments?post=478"}],"version-history":[{"count":0,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/posts\/478\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/media?parent=478"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/categories?post=478"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/tags?post=478"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/ppma_author?post=478"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}