{"id":115464,"date":"2025-11-04T20:05:10","date_gmt":"2025-11-04T20:05:10","guid":{"rendered":"https:\/\/www.newsbeep.com\/il\/115464\/"},"modified":"2025-11-04T20:05:10","modified_gmt":"2025-11-04T20:05:10","slug":"fda-issues-draft-guidance-on-qmsr-information-for-premarket-submissions","status":"publish","type":"post","link":"https:\/\/www.newsbeep.com\/il\/115464\/","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issues draft guidance on QMSR information for premarket submissions"},"content":{"rendered":"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FDA issues draft guidance on QMSR information for premarket submissions | RAPS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\/il\/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\/il\/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\n","protected":false},"excerpt":{"rendered":"FDA issues draft guidance on QMSR information for premarket submissions | RAPSRegulatory NewsJoanne S. EglovitchApproval\/marketing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":115465,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[33],"tags":[163,85,46,482],"class_list":{"0":"post-115464","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-medication","8":"tag-health","9":"tag-il","10":"tag-israel","11":"tag-medication"},"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/posts\/115464","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/comments?post=115464"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/posts\/115464\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/media\/115465"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/media?parent=115464"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/categories?post=115464"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/tags?post=115464"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}