{"id":311470,"date":"2019-02-12T05:45:22","date_gmt":"2019-02-12T10:45:22","guid":{"rendered":"https:\/\/www.euvolution.com\/futurist-transhuman-news-blog\/uncategorized\/the-fda-is-trying-to-figure-out-how-to-regulate-smart-pills.php"},"modified":"2019-02-12T05:45:22","modified_gmt":"2019-02-12T10:45:22","slug":"the-fda-is-trying-to-figure-out-how-to-regulate-smart-pills","status":"publish","type":"post","link":"https:\/\/www.euvolution.com\/futurist-transhuman-news-blog\/futurism\/the-fda-is-trying-to-figure-out-how-to-regulate-smart-pills.php","title":{"rendered":"The FDA Is Trying to Figure out How to Regulate Smart Pills"},"content":{"rendered":"<p><\/p><div><img loading=\"lazy\" decoding=\"async\" width=\"300\" height=\"158\" src=\"https:\/\/wp-assets.futurism.com\/2019\/02\/fda-regulate-smart-pills-300x158.jpg\" class=\"attachment-medium size-medium wp-post-image\" alt=\"\" style=\"padding-left:10px; padding-right: 10px;\"><\/div><h2>Take a Byte<\/h2><p>Recently, medical researchers have created a surge of ingestible electronics that do everything from tailoring treatments <a href=\"https:\/\/futurism.com\/the-byte\/molecular-computation-smart-pills\">based on the needs of individual cells<\/a> to <a href=\"https:\/\/futurism.com\/the-byte\/poopbots-edible-tech-gastrable\">helping you poop<\/a>.<\/p><p>As these devices become increasingly common in the lab, the U.S. Food and Drug Administration &mdash; that&rsquo;s&nbsp;the regulatory body responsible for testing and vetting pharmaceuticals and medical devices&nbsp;&mdash; is left figuring out how to deal with the weird new tech.<\/p><h2>Multiple Choice<\/h2><p>To make sense of the emerging new field of treatments, the <a href=\"https:\/\/www.fda.gov\/downloads\/RegulatoryInformation\/Guidances\/UCM630458.pdf\">FDA released a draft<\/a> of newly-proposed guidelines for how developers can get&nbsp;smart pills approved.<\/p><p>The people behind pills with electronic components <a href=\"https:\/\/www.mobihealthnews.com\/content\/fdas-new-draft-guidance-could-hinder-applications-digital-combination-products\">generally prefer<\/a> to submit to multiple approval processes,&nbsp;in order to let regulators approve the&nbsp;the pill and electronic&nbsp;components separately.&nbsp;But the new guidelines would require scientists to&nbsp;choose the single most relevant category and stick with it&nbsp;throughout the process.<\/p><h2>Uneven Hurdles<\/h2><p>The reason that developers prefer to break things up piece by piece is because the regulatory process for medical devices may be better suited for the unique challenges of&nbsp;the electronic components of smart pills.<\/p><p>Treating the whole package as one would a typical pharmaceutical may mean holding certain aspects of the treatment to different degrees of rigor than others, <em>MobiHealthNews<\/em> reports.<\/p><p><strong>READ MORE:<\/strong> <a href=\"https:\/\/www.mobihealthnews.com\/content\/fdas-new-draft-guidance-could-hinder-applications-digital-combination-products\">FDA&rsquo;s new draft guidance could hinder applications for digital combination products<\/a> [<em>MobiHealthNews<\/em>]<\/p><p><strong><em>More on edible tech: <a href=\"https:\/\/futurism.com\/the-byte\/edible-controller-gaming-gut\">An Edible Controller Moves Gaming From the Screen to Your Gut<\/a><\/em><\/strong><\/p><p>The post <a rel=\"nofollow\" href=\"https:\/\/futurism.com\/fda-regulate-smart-pills\/\">The FDA Is Trying to Figure out How to Regulate Smart Pills<\/a> appeared first on <a rel=\"nofollow\" href=\"https:\/\/futurism.com\">Futurism<\/a>.<\/p><p>Read the original post:<br><a target=\"_blank\" rel=\"nofollow\" href=\"https:\/\/futurism.com\/fda-regulate-smart-pills\/\" title=\"The FDA Is Trying to Figure out How to Regulate Smart Pills\">The FDA Is Trying to Figure out How to Regulate Smart Pills<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p> Take a Byte Recently, medical researchers have created a surge of ingestible electronics that do everything from tailoring treatments based on the needs of individual cells to helping you poop . As these devices become increasingly common in the lab, the U.S <a href=\"https:\/\/www.euvolution.com\/futurist-transhuman-news-blog\/futurism\/the-fda-is-trying-to-figure-out-how-to-regulate-smart-pills.php\">Continue reading <span class=\"meta-nav\">&rarr;<\/span><\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"limit_modified_date":"","last_modified_date":"","_lmt_disableupdate":"","_lmt_disable":"","footnotes":""},"categories":[11],"tags":[],"class_list":["post-311470","post","type-post","status-publish","format-standard","hentry","category-futurism"],"modified_by":null,"_links":{"self":[{"href":"https:\/\/www.euvolution.com\/futurist-transhuman-news-blog\/wp-json\/wp\/v2\/posts\/311470"}],"collection":[{"href":"https:\/\/www.euvolution.com\/futurist-transhuman-news-blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.euvolution.com\/futurist-transhuman-news-blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.euvolution.com\/futurist-transhuman-news-blog\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.euvolution.com\/futurist-transhuman-news-blog\/wp-json\/wp\/v2\/comments?post=311470"}],"version-history":[{"count":0,"href":"https:\/\/www.euvolution.com\/futurist-transhuman-news-blog\/wp-json\/wp\/v2\/posts\/311470\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.euvolution.com\/futurist-transhuman-news-blog\/wp-json\/wp\/v2\/media?parent=311470"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.euvolution.com\/futurist-transhuman-news-blog\/wp-json\/wp\/v2\/categories?post=311470"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.euvolution.com\/futurist-transhuman-news-blog\/wp-json\/wp\/v2\/tags?post=311470"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}