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Join us on June 20th, for an insightful webinar covering the evolution and current state of Laboratory Developed Tests (LDTs). We will briefly review the FDA's discretionary enforcement practices over the years to compare them with the newly established regulatory landscape. The webinar will dive into the new LDT rule, exploring its implications for laboratories to move their LDTs into the FDA regulated environment of in-vitro diagnostics (IVDs), identifying exempt devices, and discussing continued enforcement discretion. Register here: https://bit.ly/4enZo1r #webinar #medtech #medicaldevices #ldt #ivd #greenlightguru

The journey from a novel drug or medical device’s conception to its market approval is a meticulous process guided by scientific expertise and rigorous evaluation. One indispensable component of this process is the involvement of FDA Advisory Committees. Learn more in our latest blog here: https://lnkd.in/ePSu726i

🚨 Time's ticking! Share your insights on the FDA's LDT regulation proposals before Dec 4. Your voice matters in shaping the future of diagnostic laboratories! #FDARegulations #LDTupdate #HelixMolecularSolutions 🧪🔬 

🔬 Calling all Clinical Lab Experts! The Laboratory Developed Tests (LDTs) is changing with new regulations on the horizon. Your voice matters in this crucial shift. Share your thoughts, concerns, and insights on the impact of these regulations on the clinical lab space. #ClinicalLab #LDTRegulation #HealthcareInnovation

N E W U P D A T E F R O M F D A..... The FDA has issued new draft guidance to encourage efficient and flexible drug development programs using master protocols. Such protocols allow testing of multiple drugs or drug combinations within the same clinical trial infrastructure, saving time and resources. This guidance document is being distributed for comment purposes only. To get more insides, go with the link : https://lnkd.in/gV9DaeS9 #DrugDevelopment #ClinicalTrials #pharmaceutical #pharma #pharmaceuticals #pharmanews #pharmacology #pharmaceuticalmanufacturing #pharmaindustry #pharmaceuticalindustry #pharmacovigilance #milling #pharmaengineering #pharmaproduction #pharmarandd #randd #production #engineering #pharmaceutical  #pharma  #pharmaceuticals  #pharmanews  #pharmacology  #pharmaceuticalmanufacturing  #pharmaindustry  #pharmaceuticalindustry  #pharmacovigilance #milling  #mill  #granulation  #granules  #granular  #drybulk #wet #cosmeticsindustry #cosmeticchemist #foodandbeverageindustry #foodengineering #bangladesh

Clinical Laboratories should begin thinking about strategies for evaluating whether their laboratory developed tests (LDTs) are subject to FDA’s phaseout policy, determining the extent of FDA requirements that apply to such LDTs, and engaging with FDA@@@!!!

RAPS Regulatory Intelligence Conference The deadline for early bird pricing for the RAPS Regulatory Intelligence Conference is Tuesday May 7th. The Conference is being held in Baltimore June 5-6-7. You won't want to miss the fantastic line up of speakers and panelists from both the biopharma and medical device industries. #raps #regulatoryintelligence .

🔬 Navigating the New Norm: FDA Oversight of LDTs 🔬 The landscape of Laboratory Developed Tests (LDTs) is shifting. With the FDA set to phase out enforcement discretion, labs must understand the implications of the new IVD regulatory paradigm. Our blog post, "A Product Development Plan for my Laboratory Developed Test," delves into the anticipated changes and offers a strategic guide for transitioning from CLIA-certified LDTs to FDA-cleared/approved IVDs. Discover the essential steps for a robust Product Development Plan (PDP), the importance of gap analysis, and how to align with the new FDA rule. Whether you're a device manufacturer or a CLIA lab, this post is your roadmap to navigating the evolving regulatory landscape. 👉 Stay ahead of the curve and ensure your LDTs meet the new standards. Read the full blog now: https://lnkd.in/g-MaJXcW #LDT #IVD #FDARegulations #MedicalDevices #ProductDevelopment #NAMSAKnows

FDA's Final Guidance on Medical Device Voluntary Improvement Program FDA Finalizes VIP Guidance: The FDA has released its final guidance on the Medical Device Voluntary Improvement Program (VIP). VIP Complements Inspections: VIP, managed by MDIC, is not a substitute for FDA inspections, but an additional industry collaboration. Clearer Guidance for Industry: The updated guidance offers enhanced clarity based on industry feedback, explaining the program's benefits and alignment with regulations. Notable Changes: The FDA has introduced changes, including modifications to appraisal models and shorter review times for changes. Recognition of Alternatives: FDA recognizes other appraisal programs and maintains eligibility based on compliance with the FD&C Act, emphasizing its regulatory role. https://lnkd.in/gqCXsUvd #FDA #MedicalDevices #Regulations #QualityImprovement #IndustryInsights