Gramener’s Post

Clinical labeling is an essential component in the development of medical products. This meticulous process involves assigning precise information, such as dosage, expiration date, and storage conditions, to investigational drugs and devices throughout their research journey. IC #lifesciences experts Mahendra Salshingikar, Aditya Gupta, and Srinivas Chilukuri highlight the importance of accurate and compliant clinical labeling in ensuring patient safety and regulatory compliance. From dosage and expiration date to storage conditions, every detail matters. Accurate labeling is paramount for patient safety, regulatory compliance, and effective communication. Read more in our latest #POV >> https://lnkd.in/dnFMKAg2 #clinicaltrials #clinicallabeling #drugdevelopment #regulatorycompliance #pharma #lifesciences #medicaldevices #FDA #EMA

✨✨💫 Regulatory Jiff.... #ExpeditedProgram for #SeriousConditions — #AcceleratedApproval of Drugs and #Biologics by #FDA #FDA published the draft guidance for “Expedited Program for Serious Conditions — Accelerated Approval of Drugs and Biologics” last week which provides updated information on the agency’s proposed policies and procedures regarding accelerated approval Link: https://lnkd.in/gjKV8eEK This draft guidance addresses the criteria for determining: -Which products are candidates for accelerated approval, -The standards for granting accelerated approval (including postmarketing requirements), and -The procedures for withdrawing a product approved under the accelerated approval program. Accelerated approval is generally used in settings of #unmetmedicalneed for drugs intended for the treatment of a #serious or #lifethreatening condition. Key takeaways by #draftguidance: ⭐ #Endpoint selection- a #surrogateendpoint or a suitable intermediate clinical endpoint ⭐#Approvalconditions: Approval considerations depends on the severity, rarity, or prevalence of the condition and the availability or lack of alternative treatments ⭐Additional conditions and requirements like #postapproval studies, clinical benefit of the condition, label requirement, promotional material, and submission of progress of postapproval study ⭐Withdrawal of #acceleratedapproval: conditions like failed to conduct postapproval study, study failed to verify clinical benefit, evidences showing product is not safe or false or misleading #promotionalmaterial etc. ⭐Details are provided for statuary procedures for expedited withdrawal of accelerated approval, general considerations prior to proposing withdrawal, implementation off procedure and it’s details Follow us for regular updates here or at #KlinforscheClinicalScience #RegulatoryAffairs #RegulatoryApproval #DrugApproval #DrugDevelopment #Safety #MedicalSafety

When approaching a regulatory submission to the FDA, EMA, or other global health authorities, you need the right data-focused clinical research organization that will consistently produce cohesive, quality focused, and scientifically accurate documents! This is MMS. Click the link 👇below to read case studies, review whitepapers, and learn why Sponsors say “From day one, we were impressed with the efficient and smart decisions brought forth by MMS to bring this drug to market.” More: https://hubs.li/Q02CcmTZ0 Leave a comment on how you feel working with or for MMS! 💬 #OneMMS #pharma #drugdevelopment

When approaching a regulatory submission to the FDA, EMA, or other global health authorities, you need the right data-focused clinical research organization that will consistently produce cohesive, quality-focused, and scientifically accurate documents. This is MMS. Click the link below 👇 to read case studies, review whitepapers, and learn why sponsors say, 'From day one, we were impressed with the efficient and smart decisions brought forth by MMS to bring this drug to market.' More: https://hubs.li/Q02qg0TC0 Leave a comment on how you feel working with or for MMS!💬 #OneMMS #pharma #drugdevelopment

FDA has issued draft guidance on "Expedited Program for Serious Conditions — Accelerated Approval of Drugs and Biologics" on 05th December 2024. 👉🏽 https://lnkd.in/eEQhUzaM This draft guidance addresses the criteria for determining which products are candidates for accelerated approval, the standards for granting accelerated approval (including post marketing requirements), and the procedures for withdrawing a product approved under the accelerated approval program. #USFDA #ClinicalTrials #ClinicalResearch #Guidance #Update #Regulatory #PharmaceuticalIndustry #Drugs #Biologics

The FDA has today announced a final guidance "510(k) Third Party Review Program and Third Party Emergency Use Authorization Review" This document supersedes “510(k) Third Party Review Program; Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations” issued on March 12, 2020. For more MedTech, Pharma, BioTech News, Regulatory Intelligence, PMS automation, Clinical Literature automation, Research, Intelligence and much more, log onto www.medboard.com or contact us at MedBoard.   #intelligence #notifiedbody #audit #medboard #medicaldevices #medtech #eumdr #hospital #medicaldevice #fda #RegulatoryAffairs #regulatoryintelligence #clinicalinvestigations #510k

📢 Exciting News in Drug Interaction Studies! On August 2, the FDA issued the final guidance on M12 Drug Interaction Studies, setting new standards and expectations for industry practices. This crucial update is designed to streamline drug interaction studies and enhance the clarity and reliability of the data we all depend on. 💡 Why It Matters: The guidance provides detailed recommendations on study design, data interpretation, and reporting for drug-drug interactions. Adhering to these guidelines is essential for ensuring that new medications are safe and effective, and for navigating the regulatory landscape smoothly. 👋 How We Can Help: Navigating these new guidelines can be complex. At Grand Strand Clinical Trial Services, we specialize in delivering high-quality medical writing services tailored to the latest regulatory requirements. Our team of experts is well-versed in the nuances of the M12 guidance and is here to support you every step of the way. ✍ Our Services Include: - Comprehensive regulatory document preparation - In-depth analysis and reporting - Expert guidance on study design and execution - Tailored solutions to ensure compliance and streamline submissions Let us help you stay ahead of the curve and ensure your drug interaction studies meet the latest standards with precision and clarity. Reach out to us to learn more! 📞 #druginteractionstudies #FDAGuidance #medicalwriting #IndustryUpdate #Biotech #Pharma #GSClinical #GSCTS

ICH News!! (Good Clinical Practice) The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has published a draft guidance on "Good Clinical Practice (GCP) E6(R3) Annex 2". ICH E6(R3) Annex 2 addresses the GCP considerations that arise from the increased use of a wider range of design elements and data sources. Annex 2 provides additional GCP considerations, focusing on examples of trials that incorporate decentralised elements, pragmatic elements and/or real-world data (RWD). The E6(R3) Expert Working Group (EWG) is working on the revision of the E6(R2) Guideline “Good Clinical Practice” with a view to addressing the application of GCP principles to the increasingly diverse trial types and data sources being employed to support regulatory and healthcare related decision-making on drugs, and provide flexibility whenever appropriate to facilitate the use of technological innovations in clinical trials. For more MedTech, Pharma, BioTech News, Regulatory Intelligence, PMS automation, Clinical Literature automation, Research, Intelligence and much more, log onto www.medboard.com or contact us. #intelligence #notifiedbody #notifiedbodies #audit #medboard #medicaldevices #medtech #ivdr #mdr #medicaldevice #medicaldevices #surveillance #automation #regulatoryintelligence #clinicalinvestigations #pharma #clinicaltrial #ich #cta #gcp

𝗘𝗨 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗠𝗮𝘇𝗲: 𝗛𝗼𝘄 𝘁𝗼 𝗨𝗻𝗹𝗼𝗰𝗸 𝗦𝘂𝗰𝗰𝗲𝘀𝘀 𝗳𝗼𝗿 𝗗𝗿𝘂𝗴-𝗗𝗲𝘃𝗶𝗰𝗲 𝗖𝗼𝗺𝗯𝗶𝗻𝗮𝘁𝗶𝗼𝗻 𝗣𝗿𝗼𝗱𝘂𝗰𝘁𝘀 In the fast-evolving world of healthcare innovation, Drug-Device Combination Products (DDCPs) present incredible opportunities—but they also come with complex regulatory hurdles. With overlapping requirements from both pharmaceutical and medical device frameworks, bringing these products to market can feel like an unsolvable puzzle. At regenold GmbH, we take pride in being experts in navigating this maze. Our deep understanding of global regulations and our hands-on experience in guiding DDCPs to market make us the trusted partner you need. We streamline the entire process, minimizing delays and maximizing your product’s potential. 🔍 𝗟𝗼𝗼𝗸𝗶𝗻𝗴 𝗳𝗼𝗿 𝗴𝘂𝗶𝗱𝗮𝗻𝗰𝗲? https://lnkd.in/eQ_3nP9A We’ve just launched our 𝗢𝗻𝗹𝗶𝗻𝗲 𝗚𝘂𝗶𝗱𝗲 𝘁𝗼 𝗗𝗿𝘂𝗴-𝗗𝗲𝘃𝗶𝗰𝗲 𝗖𝗼𝗺𝗯𝗶𝗻𝗮𝘁𝗶𝗼𝗻 𝗣𝗿𝗼𝗱𝘂𝗰𝘁𝘀, packed with key insights to help you tackle: • Working with Notified Bodies • Obligations concerning MDR, GMP requirements, and specific national laws • How to perform Post-market surveillance • Products not yet defined by existing frameworks …and much more! Check it out here: https://lnkd.in/eQ_3nP9A Don't let regulatory challenges slow down your innovation. 𝗢𝘂𝗿 𝘁𝗲𝗮𝗺 𝗶𝘀 𝗵𝗲𝗿𝗲 𝘁𝗼 𝘀𝘂𝗽𝗽𝗼𝗿𝘁 𝘆𝗼𝘂, whether you’re looking for general advice or have specific product questions. Contact us or 𝗯𝗼𝗼𝗸 𝗮 𝗳𝗿𝗲𝗲 𝗰𝗼𝗻𝘀𝘂𝗹𝘁𝗮𝘁𝗶𝗼𝗻 today: https://lnkd.in/eAF8seky #CombinationProducts, #DrugDelivery, #MDR, #MedTech, #MedicalDevices

Did you know? In 2019, the FDA reported that almost all of new drug applications included patient experience data – and it is only getting more patient-driven. This shift towards patient-centric research is transforming how medicines are developed and approved. Hear more about this impact from our recent webinar with Emma Sutcliffe and Mark Doyle. https://ow.ly/Arwg50RXRuf #PatientEngagement #ClinicalTrials #DrugDevelopment