{"id":4117,"date":"2023-05-04T13:04:00","date_gmt":"2023-05-04T13:04:00","guid":{"rendered":"https:\/\/www.vistaar.ai\/?p=4117"},"modified":"2025-11-14T05:39:29","modified_gmt":"2025-11-14T05:39:29","slug":"pharma-biotech-usa-europe-regulatory-news-may-2023-vol-1","status":"publish","type":"post","link":"https:\/\/stage-websites.ddismart.com\/vistaar\/blog\/pharma-biotech-usa-europe-regulatory-news-may-2023-vol-1\/","title":{"rendered":"Pharma\/Biotech &#8211; USA, Europe Regulatory News, May 2023 Vol. 1"},"content":{"rendered":"\n<span class=\"wp-elements-069ead6ec051825d3da63e7635dadb1f\" id=\"usa\"><\/span><br><br>\n<h2 class=\"wp-block-heading\" style=\"background:#e2e2e2;padding:12px;\">USA<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>FDA Requests Feedback on Proposed Consumer Prescription Advertising Survey<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The FDA\u2019s Office of Prescription Drug Promotion (OPDP) is inviting public comments on its plan to study how consumers interpret quantitative information included in direct\u2011to\u2011consumer (DTC) prescription drug advertisements.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>FDA Issues Draft Guidance to Support Drug Development for Radiation Exposure<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">On 19 April, the FDA released draft guidance encouraging early and continuous communication with the agency during development of treatments intended to prevent or address acute radiation syndrome (ARS). ARS encompasses a range of clinical effects caused by high\u2011dose radiation exposure over a short period \u2014 typically within 45 minutes, according to the CDC.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>FDA Shares CMC Insights for Gene Therapy Developers During OTP Town Hall<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">At a virtual town hall held on 25 April, FDA officials from the Office of Therapeutic Products (OTP) advised gene therapy developers to avoid making manufacturing process changes during later\u2011stage pivotal studies to prevent out\u2011of\u2011specification product issues. The guidance was provided by Graeme Price, team lead for Gene Therapy Branch 1, in response to stakeholder questions regarding CMC expectations for INDs and licensure applications.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>FDA Seeks Input on Quantitative Claims in Consumer Advertising<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The OPDP has announced plans to conduct research evaluating consumer understanding of quantitative claims used in DTC advertisements. While some quantitative formats have been studied, many questions remain regarding the most effective ways to communicate such information.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>FDA Prepares for Transition to Quality Management System Regulation (QMSR)<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The agency is advancing efforts to finalize the transition from the existing Quality System Regulation (QSR) to the ISO 13485:2016\u2011aligned Quality Management System Regulation (QMSR). Internal preparations include system updates, staff training and replacement of the current Quality System Inspection Technique (QSIT).<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>FDA Releases Draft Guidance on OMOR Formatting and Content<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">A new draft guidance outlines the required format and content for over\u2011the\u2011counter (OTC) monograph order requests (OMORs). OMORs allow marketing of OTC drugs without a formal drug application, provided they are generally recognized as safe and effective (GRASE). Electronic submissions are mandatory and must include five modules: administrative information, summaries, quality, nonclinical study reports, and clinical study reports.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Final Guidance Expands FDA Recommendations on Risk\u2011Based Monitoring<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The FDA has issued updated final guidance expanding recommendations for sponsors on implementing risk\u2011based monitoring approaches in clinical trials, modernizing the agency\u2019s earlier 2013 guidance.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>FDA Requests Additional Information on Manufacturing Disruptions<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">To reduce or prevent shortages, the FDA is urging manufacturers to provide more detailed information regarding production interruptions that may affect finished drugs, biological products and some APIs.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>FDA Requires Mail\u2011Back Envelopes for Opioid Disposal<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">In an effort to address the opioid overdose crisis, the agency now requires opioid manufacturers to supply prepaid mail\u2011back envelopes to outpatient pharmacies and other dispensers, making it easier for patients to safely dispose of unused medications.<\/p>\n\n\n\n<span id=\"europe\"><\/span><br><br>\n<h2 style=\"background:#e2e2e2;padding:12px;\">EUROPE<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>EMA Becomes First Regulator to Adopt ICH S12 Guideline<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The EMA has formally adopted the ICH S12 guideline outlining best practices for conducting nonclinical biodistribution (BD) studies during development of gene therapy products.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>EU Unveils Major Drug Development Legislative Reform<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The European Union has released a sweeping proposal to overhaul pharmaceutical legislation, introducing changes affecting nearly all stages of drug development and authorization. The proposal has generated significant opposition from the pharmaceutical industry.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>EMA to Restart Publication of Clinical Trial Data<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Beginning in September, the EMA will gradually resume public release of clinical trial data for approved medical products.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>EMA Expands PRIME Pathway with New Review Features<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Updates to the EMA\u2019s Priority Medicines (PRIME) program introduce new mechanisms for monitoring product progress and improving the timeliness of scientific advice.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>EU Proposes Reforms on Compulsory Licensing and Supplementary Protection Certificates (SPCs)<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The European Commission has introduced regulations to create an EU\u2011wide compulsory licensing system for emergency use and to establish community\u2011wide SPCs that may extend patent protection for medicines by up to five years. Currently, SPCs are granted only at the national level.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>EU Publishes Draft Overhaul of Pharmaceutical Regulation<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Following several delays, the European Commission has released the draft legislation intended to reshape the pharmaceutical regulatory landscape. The proposal follows years of debate, with critics expressing concerns about potential impacts on innovation, investment and access to treatment.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>EMA Issues Reflection Paper on Single\u2011Arm Trials<\/strong><\/p>\n\n\n\n<p class=\"has-black-color has-text-color has-link-color wp-elements-780f8e0e30199f256280ec088858b17f wp-block-paragraph\">A new reflection paper offers considerations for designing single\u2011arm trials (SATs) and strategies to reduce bias when such trials are used to support marketing authorization applications. While the document encourages scientific discussion on SAT design, it does not establish general conditions for their acceptance as pivotal evidence.<\/p>\n\n\n<div style=\"color:#00bab9;font-size:16px\" class=\"taxonomy-post_tag has-link-color wp-elements-927c70617f5f183ae903ddc7892f010b wp-block-post-terms has-text-color\"><span class=\"wp-block-post-terms__prefix\"><mark style=\"background-color:#ffffff\" class=\"has-inline-color has-black-color\"><strong>Tags:<\/strong> <\/mark><\/span><a href=\"https:\/\/stage-websites.ddismart.com\/vistaar\/tag\/biotech-regulatory-news\/\" rel=\"tag\">Biotech Regulatory News<\/a><span class=\"wp-block-post-terms__separator\">, <\/span><a href=\"https:\/\/stage-websites.ddismart.com\/vistaar\/tag\/eu-regulatory-news\/\" rel=\"tag\">EU Regulatory News<\/a><span class=\"wp-block-post-terms__separator\">, <\/span><a href=\"https:\/\/stage-websites.ddismart.com\/vistaar\/tag\/european-medicines-agency\/\" rel=\"tag\">European Medicines Agency<\/a><span class=\"wp-block-post-terms__separator\">, <\/span><a href=\"https:\/\/stage-websites.ddismart.com\/vistaar\/tag\/pharma-regulatory-news\/\" rel=\"tag\">Pharma Regulatory News<\/a><span class=\"wp-block-post-terms__separator\">, <\/span><a href=\"https:\/\/stage-websites.ddismart.com\/vistaar\/tag\/regulatory-news\/\" rel=\"tag\">Regulatory News<\/a><span class=\"wp-block-post-terms__separator\">, <\/span><a href=\"https:\/\/stage-websites.ddismart.com\/vistaar\/tag\/us-fda\/\" rel=\"tag\">US FDA<\/a><span class=\"wp-block-post-terms__separator\">, <\/span><a href=\"https:\/\/stage-websites.ddismart.com\/vistaar\/tag\/usa-regulatory-news\/\" rel=\"tag\">USA Regulatory News<\/a><\/div>","protected":false},"excerpt":{"rendered":"<p>USA FDA Requests Feedback on Proposed Consumer Prescription Advertising Survey The FDA\u2019s Office of Prescription Drug Promotion (OPDP) is inviting public comments on its plan to study how consumers interpret quantitative information included in direct\u2011to\u2011consumer (DTC) prescription drug advertisements. FDA Issues Draft Guidance to Support Drug Development for Radiation Exposure On 19 April, the FDA [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":1951,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[639],"tags":[122,121,238,123,112,237,124],"class_list":["post-4117","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-biopharma","tag-biotech-regulatory-news","tag-eu-regulatory-news","tag-european-medicines-agency","tag-pharma-regulatory-news","tag-regulatory-news","tag-us-fda","tag-usa-regulatory-news"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\r\n<title>Pharma\/Biotech - USA, Europe Regulatory News, May 2023 Vol. 1<\/title>\r\n<meta name=\"description\" content=\"Pharma\/BioTech - USA, Europe Regulatory News, May 2023 Vol. 1\" \/>\r\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\r\n<link rel=\"canonical\" href=\"https:\/\/stage-websites.ddismart.com\/vistaar\/blog\/pharma-biotech-usa-europe-regulatory-news-may-2023-vol-1\/\" \/>\r\n<meta property=\"og:locale\" content=\"en_US\" \/>\r\n<meta property=\"og:type\" content=\"article\" \/>\r\n<meta property=\"og:title\" content=\"Pharma\/Biotech - USA, Europe Regulatory News, May 2023 Vol. 1\" \/>\r\n<meta property=\"og:description\" content=\"Pharma\/BioTech - USA, Europe Regulatory News, May 2023 Vol. 1\" \/>\r\n<meta property=\"og:url\" content=\"https:\/\/stage-websites.ddismart.com\/vistaar\/blog\/pharma-biotech-usa-europe-regulatory-news-may-2023-vol-1\/\" \/>\r\n<meta property=\"og:site_name\" content=\"Vistaar\" \/>\r\n<meta property=\"article:published_time\" content=\"2023-05-04T13:04:00+00:00\" \/>\r\n<meta property=\"article:modified_time\" content=\"2025-11-14T05:39:29+00:00\" \/>\r\n<meta property=\"og:image\" content=\"https:\/\/stage-websites.ddismart.com\/vistaar\/wp-content\/uploads\/2024\/01\/Biopharma-min.jpg\" \/>\r\n\t<meta property=\"og:image:width\" content=\"1200\" \/>\r\n\t<meta property=\"og:image:height\" content=\"555\" \/>\r\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\r\n<meta name=\"author\" content=\"admin\" \/>\r\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\r\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"4 minutes\" \/>\r\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/stage-websites.ddismart.com\\\/vistaar\\\/blog\\\/pharma-biotech-usa-europe-regulatory-news-may-2023-vol-1\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/stage-websites.ddismart.com\\\/vistaar\\\/blog\\\/pharma-biotech-usa-europe-regulatory-news-may-2023-vol-1\\\/\"},\"author\":{\"name\":\"admin\",\"@id\":\"https:\\\/\\\/stage-websites.ddismart.com\\\/vistaar\\\/#\\\/schema\\\/person\\\/d62b304dd6b8cc3c3b5f77783874af43\"},\"headline\":\"Pharma\\\/Biotech &#8211; 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