{"id":13003,"date":"2021-01-19T05:24:00","date_gmt":"2021-01-19T10:24:00","guid":{"rendered":"https:\/\/en.ennov.com\/?p=13003"},"modified":"2022-05-06T09:28:06","modified_gmt":"2022-05-06T14:28:06","slug":"fda-guidance-civil-money-penalties-clinicaltrials-gov","status":"publish","type":"post","link":"https:\/\/dqdev.co\/ennov\/blog\/clinical-blog\/fda-guidance-civil-money-penalties-clinicaltrials-gov\/","title":{"rendered":"FDA Issues Final Guidance on Civil Money Penalties Relating to ClinicalTrials.gov"},"content":{"rendered":"\n<p>FDA has issued a final guidance document on <a href=\"https:\/\/www.fda.gov\/media\/113361\/download\" rel=\"noreferrer noopener\" target=\"_blank\">Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank<\/a>.&nbsp; This draft guidance was first issued in 2018 and has been revised with industry comments.<\/p>\n\n\n\n<p>Section 303(f)(3) of the Federal Food, Drug, and Cosmetic Act (FD&amp;C Act) authorizes&nbsp;FDA to assess civil money penalties against submitters of certain applications and submissions to FDA regarding drug who violate requirements to submit required information, including information required for <a href=\"http:\/\/clinicaltrials.gov\" target=\"_blank\" rel=\"noreferrer noopener\">clinicaltrials.gov<\/a>.<\/p>\n\n\n\n<p>The guidance covers:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>How FDA intends to identify whether responsible parties have failed to submit required information, or have submitted false or misleading information (including results information)<\/li><li>Circumstances under which a Center may decide to seek civil money penalties against a responsible party or submitter<\/li><li>Procedures that apply when a Center seeks civil money penalties, and what civil money penalty amounts may be assessed<\/li><\/ul>\n\n\n\n<p>FDA revised the guidance to clarify that FDA does <strong>not<\/strong> intend to include on its Lists of Inspectional Observations, Forms FDA 483, any inspectional observations regarding potential violations relating to the&nbsp;<em>ClinicalTrials.gov<\/em>&nbsp;data bank.&nbsp;<\/p>\n\n\n\n<p>However, information that is collected by an investigator regarding potential violations of such requirements will be included in an Establishment Inspection Report and provided to the relevant Center for further evaluation.<\/p>\n\n\n\n<p>The Centers intend to identify potential violations of the FD&amp;C Act\u2019s requirements relating to the ClinicalTrials.gov data bank in part through evidence collected during inspections conducted as part of the FDA\u2019s BIMO program.<\/p>\n\n\n\n<p>Generally, FDA\u2019s BIMO activities are associated with the submission of a research or marketing application or are a part of the Agency\u2019s investigation of a complaint. When evaluating potential violations identified during these activities, FDA intends to utilize a risk-based approach to determine the situations in which Pre-Notice Letters will be issued, consistent with FDA\u2019s public health mission, and how the Agency approaches its other compliance programs. Submitters with a pattern of noncompliance are more likely to be identified.<\/p>\n\n\n\n<p>The FDA intends to take into consideration any corrective action taken by a responsible party or submitter after receiving a Notice of Noncompliance.<\/p>\n\n\n\n<p>The guidance further explains that the FDA intends to post Notices of Noncompliance on its website and to transmit the Notices of Noncompliance to the National Institutes of Health (NIH).\u00a0As a result, the public will experience greater transparency when seeking to understand the accuracy of information posted on <a href=\"http:\/\/clinical.gov\" target=\"_blank\" rel=\"noreferrer noopener\"><a href=\"http:\/\/clinicaltrials.gov\" target=\"_blank\" rel=\"noreferrer noopener\">clinicaltrials.gov<\/a><\/a>.<\/p>\n\n\n\n<p>It\u2019s clear that the FDA is increasing scrutiny of <a href=\"http:\/\/clinicaltrials.gov\" target=\"_blank\" rel=\"noreferrer noopener\">clinicaltrials.gov<\/a> information and preparing to apply monetary penalties (or hoping that the threat of such will increase compliance).&nbsp;<\/p>\n\n\n\n<p>The <a href=\"https:\/\/en.ennov.com\/solutions\/clinical\/ctms\/\" target=\"_blank\" rel=\"noreferrer noopener\">Ennov CTMS solution<\/a> is built on a principle of collecting timely and accurate data to drive <a href=\"http:\/\/clinicaltrials.gov\" target=\"_blank\" rel=\"noreferrer noopener\">clinicaltrials.gov<\/a> submissions.&nbsp;Please contact us if you would like to learn more about how we can assist you in generating timely and accurate submissions.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>FDA has issued a final guidance document on Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank.&nbsp; This draft guidance was first issued in 2018 and has been revised with industry comments. Section 303(f)(3) of the Federal Food, Drug, and Cosmetic Act (FD&amp;C Act) authorizes&nbsp;FDA to assess civil money penalties against submitters of certain applications [&hellip;]<\/p>\n","protected":false},"author":232,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"content-type":"","footnotes":""},"categories":[150],"tags":[],"type_content":[],"job":[],"employees_type":[],"class_list":["post-13003","post","type-post","status-publish","format-standard","hentry","category-clinical-blog","entry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v19.2.1 (Yoast SEO v27.4) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>FDA Issues Final Guidance on Civil Money Penalties<\/title>\n<meta name=\"description\" content=\"The guidance cover how FDA intends to identify whether responsible parties have failed to submit required 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