{"id":10191,"date":"2017-11-08T08:00:00","date_gmt":"2017-11-08T16:00:00","guid":{"rendered":"http:\/\/www.foodanddrugrecall.org\/index.php\/statement-from-fda-commissioner-scott-gottlieb-m-d-on-new-steps-to-improve-fda-review-of-shared-risk-evaluation-and-mitigation-strategies-to-improve-generic-drug-access\/"},"modified":"2017-11-08T08:00:00","modified_gmt":"2017-11-08T16:00:00","slug":"statement-from-fda-commissioner-scott-gottlieb-m-d-on-new-steps-to-improve-fda-review-of-shared-risk-evaluation-and-mitigation-strategies-to-improve-generic-drug-access","status":"publish","type":"post","link":"https:\/\/www.foodanddrugrecall.org\/index.php\/statement-from-fda-commissioner-scott-gottlieb-m-d-on-new-steps-to-improve-fda-review-of-shared-risk-evaluation-and-mitigation-strategies-to-improve-generic-drug-access\/","title":{"rendered":"Statement from FDA Commissioner Scott Gottlieb, M.D. on new steps to improve FDA review of shared Risk Evaluation and Mitigation Strategies to improve generic drug access"},"content":{"rendered":"<p>To further streamline the submission and review process for shared system REMS (for any REMS that includes more than one medication), today the FDA is releasing a draft guidance for industry, Use of a Drug Master File for Shared System REMS Submissions, that describes how applicants can submit collective sets of files to the FDA that represent all participating firms.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>To further streamline the submission and review process for shared system REMS (for any REMS that includes more than one medication), today the FDA is releasing a draft guidance for industry, Use of a Drug Master File for Shared System REMS Submissions, that describes how applicants can submit collective sets of files to the FDA &hellip; <a href=\"https:\/\/www.foodanddrugrecall.org\/index.php\/statement-from-fda-commissioner-scott-gottlieb-m-d-on-new-steps-to-improve-fda-review-of-shared-risk-evaluation-and-mitigation-strategies-to-improve-generic-drug-access\/\" class=\"more-link\">Continue reading <span class=\"screen-reader-text\">Statement from FDA Commissioner Scott Gottlieb, M.D. on new steps to improve FDA review of shared Risk Evaluation and Mitigation Strategies to improve generic drug access<\/span> <span class=\"meta-nav\">&rarr;<\/span><\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"1","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[14,4,3,6],"tags":[],"class_list":["post-10191","post","type-post","status-publish","format-standard","hentry","category-drug-reacalls-safety-notices-information","category-drug-safety-information-podcasts","category-food-drug-recalls","category-food-safety-news"],"_links":{"self":[{"href":"https:\/\/www.foodanddrugrecall.org\/index.php\/wp-json\/wp\/v2\/posts\/10191","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.foodanddrugrecall.org\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.foodanddrugrecall.org\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.foodanddrugrecall.org\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.foodanddrugrecall.org\/index.php\/wp-json\/wp\/v2\/comments?post=10191"}],"version-history":[{"count":0,"href":"https:\/\/www.foodanddrugrecall.org\/index.php\/wp-json\/wp\/v2\/posts\/10191\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.foodanddrugrecall.org\/index.php\/wp-json\/wp\/v2\/media?parent=10191"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.foodanddrugrecall.org\/index.php\/wp-json\/wp\/v2\/categories?post=10191"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.foodanddrugrecall.org\/index.php\/wp-json\/wp\/v2\/tags?post=10191"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}