{"id":11586,"date":"2010-11-01T06:54:50","date_gmt":"2010-11-01T10:54:50","guid":{"rendered":"http:\/\/asweetlife.org\/?p=11586"},"modified":"2015-12-30T02:46:51","modified_gmt":"2015-12-30T07:46:51","slug":"fda-issue-complete-response-letter-to-biodel-new-diabetes-drug-application","status":"publish","type":"post","link":"https:\/\/asweetlife.org\/?p=11586","title":{"rendered":"FDA Issues Complete Response Letter to Biodel New Diabetes Drug Application"},"content":{"rendered":"<div><a href=\"https:\/\/asweetlife.org\/wp-content\/uploads\/2010\/11\/biodel_logo.png\" rel=\"mfp\"><img decoding=\"async\" class=\"alignleft size-full wp-image-11588 lazyload\" title=\"biodel_logo\" src=\"data:image\/gif;base64,R0lGODlhAQABAAAAACH5BAEKAAEALAAAAAABAAEAAAICTAEAOw==\" data-src=\"https:\/\/asweetlife.org\/wp-content\/uploads\/2010\/11\/biodel_logo.png\" alt=\"\" width=\"175\" height=\"75\" \/><\/a>The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) requesting additional information regarding Biodel Inc.&#8217;s new drug application (NDA) for Linjeta a more-rapid-acting human insulin injection for the treatment of type 1 and type 2 diabetes.<\/p>\n<p>The CRL stated that the FDA&#8217;s review cycle is complete and that the application cannot be approved in its present form.The CRL included comments related to clinical trials, statistical analysis and chemistry, manufacturing and controls.<\/p>\n<p>Biodel plans to contact the FDA within the coming weeks to request a meeting to discuss the company&#8217;s next steps and requirements for approval of Linjeta(TM).<\/p>\n<\/div>\n<div>For more on <a href=\"https:\/\/asweetlife.org\/a-sweet-life-staff\/featured\/better-faster-stronger-creating-ultra-rapid-insulin\/8843\/\">Ultra Rapid Insulin<\/a>.<\/div>\n","protected":false},"excerpt":{"rendered":"<p>The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) requesting additional information regarding Biodel Inc.&#8217;s new drug application (NDA) for Linjeta a more-rapid-acting human insulin injection for the treatment of type 1 and type 2 diabetes.<br \/>\nThe CRL stated that the FDA&#8217;s review cycle is complete and that the application cannot be&#8230;<\/p>\n","protected":false},"author":131,"featured_media":11588,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_relevanssi_hide_post":"","_relevanssi_hide_content":"","_relevanssi_pin_for_all":"","_relevanssi_pin_keywords":"","_relevanssi_unpin_keywords":"","_relevanssi_related_keywords":"","_relevanssi_related_include_ids":"","_relevanssi_related_exclude_ids":"","_relevanssi_related_no_append":"","_relevanssi_related_not_related":"","_relevanssi_related_posts":"","_relevanssi_noindex_reason":"","footnotes":""},"categories":[1441],"tags":[862],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v22.9 (Yoast SEO v22.9) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ 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