{"id":262760,"date":"2025-11-04T20:49:15","date_gmt":"2025-11-04T20:49:15","guid":{"rendered":"https:\/\/www.newsbeep.com\/au\/262760\/"},"modified":"2025-11-04T20:49:15","modified_gmt":"2025-11-04T20:49:15","slug":"fda-issues-draft-guidance-on-qmsr-information-for-premarket-submissions","status":"publish","type":"post","link":"https:\/\/www.newsbeep.com\/au\/262760\/","title":{"rendered":"FDA issues draft guidance on QMSR information for premarket submissions"},"content":{"rendered":"<p>FDA issues draft guidance on QMSR information for premarket submissions | RAPS<img decoding=\"async\" class=\"category-img\" itemprop=\"image\" alt=\"Regulatory News\" src=\"https:\/\/www.newsbeep.com\/au\/wp-content\/uploads\/2025\/11\/news.png\"\/>Regulatory News<a href=\"https:\/\/www.raps.org\/news-and-articles\/news-articles?author=1d35db73-6e33-4289-af2f-78169a8ea747\" itemprop=\"url\" rel=\"nofollow noopener\" target=\"_blank\">Joanne S. Eglovitch<\/a><img decoding=\"async\" itemprop=\"image\" src=\"https:\/\/www.newsbeep.com\/au\/wp-content\/uploads\/2025\/11\/webimage-FDA_Sign_250806_ALF.png\"\/>Approval\/marketing authorizationAudit\/inspectionCDRHComplianceEnforcementGuidanceMedical DevicesProduct developmentProduct LifecycleQuality Assurance and ControlQuality management system\/QMSRegulatory Intelligence\/PolicyRegulatory strategyUnited StatesUS Food and Drug Administration (FDA)<\/p>\n","protected":false},"excerpt":{"rendered":"FDA issues draft guidance on QMSR information for premarket submissions | RAPSRegulatory NewsJoanne S. EglovitchApproval\/marketing authorizationAudit\/inspectionCDRHComplianceEnforcementGuidanceMedical DevicesProduct developmentProduct&hellip;\n","protected":false},"author":2,"featured_media":262761,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[33],"tags":[64,63,137,490],"class_list":["post-262760","post","type-post","status-publish","format-standard","has-post-thumbnail","category-medication","tag-au","tag-australia","tag-health","tag-medication"],"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/posts\/262760","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/comments?post=262760"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/posts\/262760\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/media\/262761"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/media?parent=262760"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/categories?post=262760"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/tags?post=262760"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}