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US FDA/UK MHRA/Health Canada News (Transparency for Machine Learning-Enabled Medical Devices) The U.S. Food and Drug Administration (FDA), Health Canada, and the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) have jointly released 'Transparency for Machine Learning-Enabled Medical Devices: Guiding Principles' In this document, FDA, Health Canada, and MHRA jointly identified guiding principles for transparency for machine learning-enabled medical devices (MLMDs). These principles build upon the guiding principles for Good Machine Learning Practice (GMLP) which were published in 2021. These guiding principles are intended as considerations when adopting and advancing good transparency practices. #FDA #MHRA #HealthCanada

The need for an aligned approach to regulatory and scientific requirements, is explored and it is important for expanding patient access in the future ! Must read article !

According to ABHI's Richard Devereaux Phillips, the #UK’s Medicines and Healthcare products Regulatory Agency is preparing to deploy an international recognition framework for #medicaldevices that would allow #medicaldevice manufacturers to bring products to the UK more easily.   #Didyouknow 📌 The #MHRA has announced the International Recognition Procedure  #IRP intended to replace the EC Decision Reliance Procedure  #ECDRP starting January 1st, 2024. Read more about the procedure here: https://lnkd.in/dUxXTqdK IRP will be open to applicants that have already received an authorisation for the same product from one of #MHRA’s specified  #ReferenceRegulators #RRs, i.e., for the purposes of IRO, a #CHMP positive opinion or an #MRDC positive end of procedure outcome is an RR authorisation. IRP can be used for the following types of  #marketingauthorisation  applications #MAAs: 👉 Regulation 50: chemical and biological new #activesubstances and known active substances. 👉 Regulation 51, 51A and 51B: #generic applications 👉 Regulation 52, 52A and 52B: hybrid applications 👉 Regulation 55: new fixed #combinationproducts applications IRP will be open to applicants with existing authorizations from Reference regulators, namely #Australia's Therapeutic Goods Administration,  #Canada's Health Canada | Santé Canada, #Switzerland's Swissmedic,  #Singapore's Health Science Authority Singapore #HSA, Japan's  #PMDA, #USA's FDA, and European Union's European Medicines Agency  and #MemberStates #Competent Authorities. #InternationalRecognitionProcedure #pharma #pharmaindustry

👇 It is good to be heard! See below for how to comment on FDA guidances!

The U.S. Food and Drug Administration (#FDA), #HealthCanada, and the Medicines and Healthcare products Regulatory Agency (#MHRA) have jointly issued the “𝐓𝐫𝐚𝐧𝐬𝐩𝐚𝐫𝐞𝐧𝐜𝐲 𝐟𝐨𝐫 𝐌𝐚𝐜𝐡𝐢𝐧𝐞 𝐋𝐞𝐚𝐫𝐧𝐢𝐧𝐠-𝐄𝐧𝐚𝐛𝐥𝐞𝐝 𝐌𝐞𝐝𝐢𝐜𝐚𝐥 𝐃𝐞𝐯𝐢𝐜𝐞𝐬: 𝐆𝐮𝐢𝐝𝐢𝐧𝐠 𝐏𝐫𝐢𝐧𝐜𝐢𝐩𝐥𝐞𝐬.” The Transparency for Machine Learning-Enabled Medical Devices: Guiding Principles builds upon the "𝐆𝐨𝐨𝐝 𝐌𝐚𝐜𝐡𝐢𝐧𝐞 𝐋𝐞𝐚𝐫𝐧𝐢𝐧𝐠 𝐏𝐫𝐚𝐜𝐭𝐢𝐜𝐞 (𝐆𝐌𝐋𝐏) 𝐟𝐨𝐫 𝐌𝐞𝐝𝐢𝐜𝐚𝐥 𝐃𝐞𝐯𝐢𝐜𝐞 𝐃𝐞𝐯𝐞𝐥𝐨𝐩𝐦𝐞𝐧𝐭: 𝐆𝐮𝐢𝐝𝐢𝐧𝐠 𝐏𝐫𝐢𝐧𝐜𝐢𝐩𝐥𝐞𝐬" and the"𝐏𝐫𝐞𝐝𝐞𝐭𝐞𝐫𝐦𝐢𝐧𝐞𝐝 𝐂𝐡𝐚𝐧𝐠𝐞 𝐂𝐨𝐧𝐭𝐫𝐨𝐥 𝐏𝐥𝐚𝐧𝐬 𝐟𝐨𝐫 𝐌𝐚𝐜𝐡𝐢𝐧𝐞 𝐋𝐞𝐚𝐫𝐧𝐢𝐧𝐠-𝐄𝐧𝐚𝐛𝐥𝐞𝐝 𝐌𝐞𝐝𝐢𝐜𝐚𝐥 𝐃𝐞𝐯𝐢𝐜𝐞𝐬: 𝐆𝐮𝐢𝐝𝐢𝐧𝐠 𝐏𝐫𝐢𝐧𝐜𝐢𝐩𝐥𝐞𝐬" both published jointly by the FDA, Health Canada and MHRA. Transparency across health care must be an international priority. Read documents here: https://lnkd.in/eHqupz_i https://lnkd.in/eGqcaY4k

📰 The Food and Drug Administration (FDA) seeks input on health equity for medical devices to help shape a potential regulatory approach. This feedback will develop a framework for evaluating when devices should be tested in diverse populations to support their marketing authorization. The FDA's discussion paper is open for comments until October 4th. Learn more in this curated blog 👉 https://ow.ly/vxbt50TeBy5 #medicaldevice #fda

𝐅𝐃𝐀 𝐅𝐈𝐍𝐀𝐋𝐈𝐙𝐄𝐒 𝐆𝐔𝐈𝐃𝐀𝐍𝐂𝐄 𝐎𝐍 𝐔𝐒𝐈𝐍𝐆 𝐑𝐄𝐀𝐋-𝐖𝐎𝐑𝐋𝐃 𝐃𝐀𝐓𝐀 𝐅𝐎𝐑 𝐑𝐄𝐆𝐔𝐋𝐀𝐓𝐎𝐑𝐘 𝐃𝐄𝐂𝐈𝐒𝐈𝐎𝐍𝐒 We are excited to share that the FDA has released final guidance on utilizing Electronic Health Records (EHRs) and medical claims data to support regulatory decisions for drug products: https://lnkd.in/geANjjW7 This release marks a significant step in the Real-World Evidence (RWE) Program, enhancing the integration of real-world data (RWD) in clinical studies. The guidance outlines essential considerations for ensuring data reliability and relevance, addressing key study elements, and maintaining rigorous quality assurance. This is a crucial development for sponsors aiming to leverage RWE to demonstrate drug safety and effectiveness. #RealWorldEvidence #FDA #ClinicalResearch #HealthcareInnovation

The Heads of Medicines Agencies (HMA) releases recommendation paper on principles of GLP for clinical trial applications under the EU Clinical Trials Regulation. - Do you require support transitioning your clinical trial? Get in touch to speak to a member of our team - www.scendea.com/contact - #guidanceupdate #regulatoryaffairs #drugdevelopment #clinicaltrialregulation

The U.S. Food and Drug Administration (#FDA),#HealthCanada, and the Medicines and Healthcare products Regulatory Agency (#MHRA) have jointly issued the “𝐓𝐫𝐚𝐧𝐬𝐩𝐚𝐫𝐞𝐧𝐜𝐲 𝐟𝐨𝐫 𝐌𝐚𝐜𝐡𝐢𝐧𝐞 𝐋𝐞𝐚𝐫𝐧𝐢𝐧𝐠-𝐄𝐧𝐚𝐛𝐥𝐞𝐝 𝐌𝐞𝐝𝐢𝐜𝐚𝐥 𝐃𝐞𝐯𝐢𝐜𝐞𝐬: 𝐆𝐮𝐢𝐝𝐢𝐧𝐠 𝐏𝐫𝐢𝐧𝐜𝐢𝐩𝐥𝐞𝐬.” The Transparency for Machine Learning-Enabled Medical Devices: Guiding Principles builds upon the "𝐆𝐨𝐨𝐝 𝐌𝐚𝐜𝐡𝐢𝐧𝐞 𝐋𝐞𝐚𝐫𝐧𝐢𝐧𝐠 𝐏𝐫𝐚𝐜𝐭𝐢𝐜𝐞 (𝐆𝐌𝐋𝐏) 𝐟𝐨𝐫 𝐌𝐞𝐝𝐢𝐜𝐚𝐥 𝐃𝐞𝐯𝐢𝐜𝐞 𝐃𝐞𝐯𝐞𝐥𝐨𝐩𝐦𝐞𝐧𝐭: 𝐆𝐮𝐢𝐝𝐢𝐧𝐠 𝐏𝐫𝐢𝐧𝐜𝐢𝐩𝐥𝐞𝐬" and the"𝐏𝐫𝐞𝐝𝐞𝐭𝐞𝐫𝐦𝐢𝐧𝐞𝐝 𝐂𝐡𝐚𝐧𝐠𝐞 𝐂𝐨𝐧𝐭𝐫𝐨𝐥 𝐏𝐥𝐚𝐧𝐬 𝐟𝐨𝐫 𝐌𝐚𝐜𝐡𝐢𝐧𝐞 𝐋𝐞𝐚𝐫𝐧𝐢𝐧𝐠-𝐄𝐧𝐚𝐛𝐥𝐞𝐝 𝐌𝐞𝐝𝐢𝐜𝐚𝐥 𝐃𝐞𝐯𝐢𝐜𝐞𝐬: 𝐆𝐮𝐢𝐝𝐢𝐧𝐠 𝐏𝐫𝐢𝐧𝐜𝐢𝐩𝐥𝐞𝐬" both published jointly by the FDA, Health Canada and MHRA. Transparency across health care must be an international priority. Read documents here: https://lnkd.in/dK-X6-Zw https://lnkd.in/ejqWRmV3

📣 Speak up! This is how you can engage with the FDA today!   FDA guidances, notices, and rules are published throughout the year, but especially during the spring and fall. With anything recently issued by the FDA, it is important to make sure your thoughts are considered. FDA typically allows 60 days for public input. Below are 3 steps on how to make sure FDA hears your voice during an open comment period.   ✅ Step 1) Within regulations.gov, enter docket number if known (e.g., FDA-2023-N-0061) or by keyword into the search bar ✅ Step 2) Refine Document results by selecting “Only show documents open for comment” and navigating to Agency, selecting Food and Drug Administration ✅ Step 3) Once you find your document of interest, select the “Comment” button and type in your comment and hit submit at the bottom of the page Healthcare Innovation Catalysts invites you to explore the links below: Drugs: Dive into the latest drug-related guidance documents https://lnkd.in/dE3jbQXQ CDRH: Explore proposed guidance documents from the Center for Devices and Radiological Health https://lnkd.in/duAuwTaZ. Seize this opportunity to shape the future of healthcare! Your insights matter! #FDA #guidance #commentary #speakup #regulation #publiccomment #healthcare