{"id":39190,"date":"2025-08-13T12:10:06","date_gmt":"2025-08-13T04:10:06","guid":{"rendered":"https:\/\/flcube.com\/?p=39190"},"modified":"2025-08-13T12:10:07","modified_gmt":"2025-08-13T04:10:07","slug":"fda-launches-precheck-program-to-strengthen-u-s-pharmaceutical-supply-chain","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=39190","title":{"rendered":"FDA Launches PreCheck Program to Strengthen U.S. Pharmaceutical Supply Chain"},"content":{"rendered":"\n<p>The U.S. Food and Drug Administration (FDA) announced the launch of &#8220;FDA PreCheck&#8221; on August 7, 2025. This new program aims to strengthen the domestic pharmaceutical supply chain by increasing regulatory predictability and encouraging the construction of manufacturing facilities within the United States.<\/p>\n\n\n\n<p><strong>Current Reliance on Foreign Manufacturing<\/strong><br>More than half of the pharmaceuticals distributed in the U.S. are currently manufactured overseas. The U.S. is also heavily reliant on foreign sources for active pharmaceutical ingredients (APIs). Only 11% of API manufacturers for FDA-approved products are based in the U.S.<\/p>\n\n\n\n<p><strong>FDA Commissioner&#8217;s Statement<\/strong><br>According to FDA Commissioner Marty Makary, M.D., M.P.H., &#8220;Our gradual overreliance on foreign drug manufacturing has created national security risks.&#8221; He emphasized that the FDA PreCheck initiative is one of many steps the FDA is taking to reverse this reliance and ensure a resilient, strong, and domestic drug supply for Americans.<\/p>\n\n\n\n<p><strong>Executive Order and Program Details<\/strong><br>FDA PreCheck was developed in response to Executive Order 14293, &#8220;Regulatory Relief to Promote Domestic Production of Critical Medicines.&#8221; The order directs the FDA to streamline its review of domestic pharmaceutical manufacturing and eliminate unnecessary regulatory requirements. The PreCheck program introduces an innovative two-phase approach to facilitate the establishment of new U.S. drug manufacturing facilities.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The U.S. Food and Drug Administration (FDA) announced the launch of &#8220;FDA PreCheck&#8221; on August&#8230;<\/p>\n","protected":false},"author":1,"featured_media":39191,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"googlesitekit_rrm_CAownpewDA:productID":"","_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[4],"tags":[],"class_list":["post-39190","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-policy-regulatory"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v23.6 (Yoast SEO v27.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>FDA Launches PreCheck Program to Strengthen U.S. Pharmaceutical Supply Chain - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"The U.S. Food and Drug Administration (FDA) announced the launch of &quot;FDA PreCheck&quot; on August 7, 2025. This new program aims to strengthen the domestic pharmaceutical supply chain by increasing regulatory predictability and encouraging the construction of manufacturing facilities within the United States.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/flcube.com\/?p=39190\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FDA Launches PreCheck Program to Strengthen U.S. Pharmaceutical Supply Chain\" \/>\n<meta property=\"og:description\" content=\"The U.S. Food and Drug Administration (FDA) announced the launch of &quot;FDA PreCheck&quot; on August 7, 2025. This new program aims to strengthen the domestic pharmaceutical supply chain by increasing regulatory predictability and encouraging the construction of manufacturing facilities within the United States.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flcube.com\/?p=39190\" \/>\n<meta property=\"og:site_name\" content=\"Insight, China&#039;s Pharmaceutical Industry\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/profile.php?id=61566606313834\" \/>\n<meta property=\"article:published_time\" content=\"2025-08-13T04:10:06+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-08-13T04:10:07+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/08\/1302.webp\" \/>\n\t<meta property=\"og:image:width\" content=\"1080\" \/>\n\t<meta property=\"og:image:height\" content=\"608\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Fineline Cube\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:description\" content=\"Navigate the complexities of China\u2019s pharmaceutical industry with precision and clarity. FLCUBE delivers reliable data, news, and intelligence to broaden your horizons and sharpen your decision-making. Stay informed, stay ahead with FLCUBE.COM\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Fineline Cube\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=39190#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=39190\"},\"author\":{\"name\":\"Fineline Cube\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/person\\\/19ad11870d326204db8524d3c3c5e66a\"},\"headline\":\"FDA Launches PreCheck Program to Strengthen U.S. Pharmaceutical Supply Chain\",\"datePublished\":\"2025-08-13T04:10:06+00:00\",\"dateModified\":\"2025-08-13T04:10:07+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=39190\"},\"wordCount\":223,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=39190#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2025\\\/08\\\/1302.webp\",\"articleSection\":[\"Policy \\\/ Regulatory\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=39190#respond\"]}],\"copyrightYear\":\"2025\",\"copyrightHolder\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"}},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=39190\",\"url\":\"https:\\\/\\\/flcube.com\\\/?p=39190\",\"name\":\"FDA Launches PreCheck Program to Strengthen U.S. Pharmaceutical Supply Chain - Insight, China&#039;s Pharmaceutical Industry\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=39190#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=39190#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2025\\\/08\\\/1302.webp\",\"datePublished\":\"2025-08-13T04:10:06+00:00\",\"dateModified\":\"2025-08-13T04:10:07+00:00\",\"description\":\"The U.S. Food and Drug Administration (FDA) announced the launch of \\\"FDA PreCheck\\\" on August 7, 2025. This new program aims to strengthen the domestic pharmaceutical supply chain by increasing regulatory predictability and encouraging the construction of manufacturing facilities within the United States.\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=39190#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=39190\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=39190#primaryimage\",\"url\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2025\\\/08\\\/1302.webp\",\"contentUrl\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2025\\\/08\\\/1302.webp\",\"width\":1080,\"height\":608,\"caption\":\"FDA Launches PreCheck Program to Strengthen U.S. Pharmaceutical Supply Chain\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=39190#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/flcube.com\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"FDA Launches PreCheck Program to Strengthen U.S. Pharmaceutical Supply Chain\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#website\",\"url\":\"https:\\\/\\\/flcube.com\\\/\",\"name\":\"Insight, China's Pharmaceutical Industry\",\"description\":\"Fineline Insights, Pharma Clarity\",\"publisher\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/flcube.com\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\",\"name\":\"Fineline Infomation and Technology\",\"alternateName\":\"Fineline Info & Tech\",\"url\":\"https:\\\/\\\/flcube.com\\\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/logo\\\/image\\\/\",\"url\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2024\\\/11\\\/Fineline-info-tech-scaled.jpg\",\"contentUrl\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2024\\\/11\\\/Fineline-info-tech-scaled.jpg\",\"width\":2560,\"height\":1894,\"caption\":\"Fineline Infomation and Technology\"},\"image\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/logo\\\/image\\\/\"},\"sameAs\":[\"https:\\\/\\\/www.facebook.com\\\/profile.php?id=61566606313834\"]},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/person\\\/19ad11870d326204db8524d3c3c5e66a\",\"name\":\"Fineline Cube\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g\",\"url\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g\",\"contentUrl\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g\",\"caption\":\"Fineline Cube\"},\"sameAs\":[\"https:\\\/\\\/flcube.com\"],\"url\":\"https:\\\/\\\/flcube.com\\\/?author=1\"}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"FDA Launches PreCheck Program to Strengthen U.S. Pharmaceutical Supply Chain - Insight, China&#039;s Pharmaceutical Industry","description":"The U.S. Food and Drug Administration (FDA) announced the launch of \"FDA PreCheck\" on August 7, 2025. This new program aims to strengthen the domestic pharmaceutical supply chain by increasing regulatory predictability and encouraging the construction of manufacturing facilities within the United States.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/flcube.com\/?p=39190","og_locale":"en_US","og_type":"article","og_title":"FDA Launches PreCheck Program to Strengthen U.S. Pharmaceutical Supply Chain","og_description":"The U.S. Food and Drug Administration (FDA) announced the launch of \"FDA PreCheck\" on August 7, 2025. This new program aims to strengthen the domestic pharmaceutical supply chain by increasing regulatory predictability and encouraging the construction of manufacturing facilities within the United States.","og_url":"https:\/\/flcube.com\/?p=39190","og_site_name":"Insight, China&#039;s Pharmaceutical Industry","article_publisher":"https:\/\/www.facebook.com\/profile.php?id=61566606313834","article_published_time":"2025-08-13T04:10:06+00:00","article_modified_time":"2025-08-13T04:10:07+00:00","og_image":[{"width":1080,"height":608,"url":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/08\/1302.webp","type":"image\/png"}],"author":"Fineline Cube","twitter_card":"summary_large_image","twitter_description":"Navigate the complexities of China\u2019s pharmaceutical industry with precision and clarity. FLCUBE delivers reliable data, news, and intelligence to broaden your horizons and sharpen your decision-making. Stay informed, stay ahead with FLCUBE.COM","twitter_misc":{"Written by":"Fineline Cube","Est. reading time":"2 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/flcube.com\/?p=39190#article","isPartOf":{"@id":"https:\/\/flcube.com\/?p=39190"},"author":{"name":"Fineline Cube","@id":"https:\/\/flcube.com\/#\/schema\/person\/19ad11870d326204db8524d3c3c5e66a"},"headline":"FDA Launches PreCheck Program to Strengthen U.S. Pharmaceutical Supply Chain","datePublished":"2025-08-13T04:10:06+00:00","dateModified":"2025-08-13T04:10:07+00:00","mainEntityOfPage":{"@id":"https:\/\/flcube.com\/?p=39190"},"wordCount":223,"commentCount":0,"publisher":{"@id":"https:\/\/flcube.com\/#organization"},"image":{"@id":"https:\/\/flcube.com\/?p=39190#primaryimage"},"thumbnailUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/08\/1302.webp","articleSection":["Policy \/ Regulatory"],"inLanguage":"en-US","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/flcube.com\/?p=39190#respond"]}],"copyrightYear":"2025","copyrightHolder":{"@id":"https:\/\/flcube.com\/#organization"}},{"@type":"WebPage","@id":"https:\/\/flcube.com\/?p=39190","url":"https:\/\/flcube.com\/?p=39190","name":"FDA Launches PreCheck Program to Strengthen U.S. Pharmaceutical Supply Chain - Insight, China&#039;s Pharmaceutical Industry","isPartOf":{"@id":"https:\/\/flcube.com\/#website"},"primaryImageOfPage":{"@id":"https:\/\/flcube.com\/?p=39190#primaryimage"},"image":{"@id":"https:\/\/flcube.com\/?p=39190#primaryimage"},"thumbnailUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/08\/1302.webp","datePublished":"2025-08-13T04:10:06+00:00","dateModified":"2025-08-13T04:10:07+00:00","description":"The U.S. Food and Drug Administration (FDA) announced the launch of \"FDA PreCheck\" on August 7, 2025. This new program aims to strengthen the domestic pharmaceutical supply chain by increasing regulatory predictability and encouraging the construction of manufacturing facilities within the United States.","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=39190#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=39190"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/flcube.com\/?p=39190#primaryimage","url":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/08\/1302.webp","contentUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/08\/1302.webp","width":1080,"height":608,"caption":"FDA Launches PreCheck Program to Strengthen U.S. Pharmaceutical Supply Chain"},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=39190#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"FDA Launches PreCheck Program to Strengthen U.S. Pharmaceutical Supply Chain"}]},{"@type":"WebSite","@id":"https:\/\/flcube.com\/#website","url":"https:\/\/flcube.com\/","name":"Insight, China's Pharmaceutical Industry","description":"Fineline Insights, Pharma Clarity","publisher":{"@id":"https:\/\/flcube.com\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/flcube.com\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Organization","@id":"https:\/\/flcube.com\/#organization","name":"Fineline Infomation and Technology","alternateName":"Fineline Info & Tech","url":"https:\/\/flcube.com\/","logo":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/flcube.com\/#\/schema\/logo\/image\/","url":"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/Fineline-info-tech-scaled.jpg","contentUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/Fineline-info-tech-scaled.jpg","width":2560,"height":1894,"caption":"Fineline Infomation and Technology"},"image":{"@id":"https:\/\/flcube.com\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.facebook.com\/profile.php?id=61566606313834"]},{"@type":"Person","@id":"https:\/\/flcube.com\/#\/schema\/person\/19ad11870d326204db8524d3c3c5e66a","name":"Fineline Cube","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/secure.gravatar.com\/avatar\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g","url":"https:\/\/secure.gravatar.com\/avatar\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g","caption":"Fineline Cube"},"sameAs":["https:\/\/flcube.com"],"url":"https:\/\/flcube.com\/?author=1"}]}},"jetpack_publicize_connections":[],"jetpack_featured_media_url":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/08\/1302.webp","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/39190","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=39190"}],"version-history":[{"count":1,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/39190\/revisions"}],"predecessor-version":[{"id":39192,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/39190\/revisions\/39192"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/media\/39191"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=39190"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=39190"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=39190"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}