{"id":20032,"date":"2022-05-06T02:18:04","date_gmt":"2022-05-06T07:18:04","guid":{"rendered":"https:\/\/en.ennov.com\/?p=20032"},"modified":"2022-05-06T07:54:18","modified_gmt":"2022-05-06T12:54:18","slug":"complete-response-letter","status":"publish","type":"post","link":"https:\/\/dqdev.co\/ennov\/glossary\/complete-response-letter\/","title":{"rendered":"Complete Response Letter"},"content":{"rendered":"\n<p>[FDA] A written communication to an applicant from FDA usually describing all of the deficiencies that the agency has identified in an application or abbreviated application that must be satisfactorily addressed before it can be approved. NOTE: The use of the Complete Response Letter discontinues FDA\u2019s use of approvable letters and not approvable letters when taking action on marketing applications.<\/p>\n\n\n\n<p>Source: <a href=\"https:\/\/www.govinfo.gov\/content\/pkg\/CFR-2011-title21-vol5\/pdf\/CFR-2011-title21-vol5-sec314-3.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">21 CFR 314.3(b)<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>[FDA] A written communication to an applicant from FDA usually describing all of the deficiencies that the agency has identified in an application or abbreviated application that must be satisfactorily addressed before it can be approved. NOTE: The use of the Complete Response Letter discontinues FDA\u2019s use of approvable letters and not approvable letters when [&hellip;]<\/p>\n","protected":false},"author":232,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"content-type":"","footnotes":""},"categories":[184,180],"tags":[],"type_content":[179],"job":[],"employees_type":[],"class_list":["post-20032","post","type-post","status-publish","format-standard","hentry","category-c","category-glossary","type_content-glossaire","entry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v19.2.1 (Yoast SEO v27.4) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Complete Response Letter<\/title>\n<meta name=\"description\" content=\"A written communication to an applicant from FDA usually describing all of the deficiencies that the agency has identified in an application 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