{"id":19072,"date":"2022-04-28T14:18:37","date_gmt":"2022-04-28T12:18:37","guid":{"rendered":"https:\/\/nanopartikel.info\/?p=19072"},"modified":"2022-04-28T14:18:37","modified_gmt":"2022-04-28T12:18:37","slug":"fda-publishes-final-guidance-for-industry-on-nanomaterials-in-drug-products","status":"publish","type":"post","link":"https:\/\/nanopartikel.info\/en\/fda-publishes-final-guidance-for-industry-on-nanomaterials-in-drug-products\/","title":{"rendered":"FDA Publishes Final Guidance for Industry on Nanomaterials in Drug Products"},"content":{"rendered":"<p>The U.S. Food and Drug Administration (<a href=\"https:\/\/www.fda.gov\/\" target=\"_blank\" rel=\"noopener\">FDA<\/a>) has published the final guidance document for industry &ldquo;<a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/drug-products-including-biological-products-contain-nanomaterials-guidance-industry\" target=\"_blank\" rel=\"noopener\">Drug Products, Including Biological Products, that Contain Nanomaterials<\/a>&rdquo; . FDA states that the guidance applies broad array of FDA-regulated products such as human drug products, including those that are biological products, in which a <span class=\"glossaryLink\" aria-describedby=\"tt\" data-cmtooltip=\"&lt;div class=glossaryItemTitle&gt;Nanomaterial&lt;\/div&gt;&lt;div class=glossaryItemBody&gt;The European Commission updated the common definition of the term &amp;quot;nanomaterial&amp;quot; in 2022:&amp;lt;br \/&amp;gt;&lsquo;Nanomaterial&rsquo; means a natural, incidental or manufactured material consisting of solid particles that are present, either on their own or as identifiable constituent particles in aggregates or agglomerates, and where 50% or more of these particles in the number-based size distribution fulfil at least one of the following conditions:\n&amp;lt;ol&amp;gt;\n \t&amp;lt;li&amp;gt;one or more external dimensions of the particle are in the size range 1 nm to 100 nm;&amp;lt;\/li&amp;gt;\n \t&amp;lt;li&amp;gt;the particle has an elongated shape, such as a rod, fibre or tube, where two external dimensions are smaller than 1 nm and the other dimension is larger than 100 nm;&amp;lt;\/li&amp;gt;\n \t&amp;lt;li&amp;gt;the particle has a plate-like shape, where one external dimension is smaller than 1 nm and the other dimensions are larger than 100 nm.&amp;lt;\/li&amp;gt;\n \t&amp;lt;li&amp;gt;In the determination of the particle number-based size distribution, particles with at least two orthogonal external dimensions larger than 100 &mu;m need not be considered.&amp;lt;\/li&amp;gt;\n&amp;lt;\/ol&amp;gt;\nHowever, a material with a specific surface area by volume of &amp;lt; 6 m&amp;lt;sup&amp;gt;2&amp;lt;\/sup&amp;gt;\/cm&amp;lt;sup&amp;gt;3&amp;lt;\/sup&amp;gt; shall not be considered a nanomaterial.&amp;lt;br \/&amp;gt;https:\/\/ec.europa.eu\/environment\/chemicals\/nanotech\/pdf\/C_2022_3689_1_EN_ACT_part1_v6.pdf&lt;\/div&gt;\" data-gt-translate-attributes='[{\"attribute\":\"data-cmtooltip\", \"format\":\"html\"}]'>nanomaterial<\/span> is present in the finished dosage form. The guidance discusses both general principles and specific considerations for developing drug products containing nanomaterials through abbreviated pathways, as well as considerations for quality, nonclinical, and clinical studies as they relate to drug products containing nanomaterials throughout product development and production.<\/p>\n<ul>\n<li>Read the full document online via <a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/drug-products-including-biological-products-contain-nanomaterials-guidance-industry\" target=\"_blank\" rel=\"noopener\">https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/drug-products-including-biological-products-contain-nanomaterials-guidance-industry<\/a><\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>The U.S. Food and Drug Administration (FDA) has published the final guidance document for industry &#8220;Drug Products, Including Biological Products, that Contain Nanomaterials\u201d . FDA states that the guidance applies broad array of FDA-regulated products such as human drug products, including those that are biological products, in which a nanomaterial is present in the finished [&hellip;]<\/p>\n","protected":false},"author":4,"featured_media":19070,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[119],"tags":[],"acf":[],"_links":{"self":[{"href":"https:\/\/nanopartikel.info\/en\/wp-json\/wp\/v2\/posts\/19072"}],"collection":[{"href":"https:\/\/nanopartikel.info\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/nanopartikel.info\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/nanopartikel.info\/en\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/nanopartikel.info\/en\/wp-json\/wp\/v2\/comments?post=19072"}],"version-history":[{"count":2,"href":"https:\/\/nanopartikel.info\/en\/wp-json\/wp\/v2\/posts\/19072\/revisions"}],"predecessor-version":[{"id":19074,"href":"https:\/\/nanopartikel.info\/en\/wp-json\/wp\/v2\/posts\/19072\/revisions\/19074"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nanopartikel.info\/en\/wp-json\/wp\/v2\/media\/19070"}],"wp:attachment":[{"href":"https:\/\/nanopartikel.info\/en\/wp-json\/wp\/v2\/media?parent=19072"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nanopartikel.info\/en\/wp-json\/wp\/v2\/categories?post=19072"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nanopartikel.info\/en\/wp-json\/wp\/v2\/tags?post=19072"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}