NDA Partners’ Post

The FDA's new Final Rule on Laboratory Developed Tests (LDTs) is here, bringing significant changes to the regulatory landscape. Wondering how this affects your lab and what steps to take next? At Velsera, we're here to help you navigate these changes seamlessly. Discover our customized resources, expert insights, and innovative solutions designed to support your lab through this transition. https://lnkd.in/edNmParT   Let's navigate the future of LDTs together! 

Need help with new #FDA ruling on #NGS #LDT #RUO and #IVD #Clinical #Oncology compliance? #Velsera provides this blog to ensure latest and greatest insights for our #Laboratory colleagues. #Sequencing #Molecular #Bioinformatics #Compliance #Genetics

CALLING THE COMPANION DIAGNOSTIC COMMUNITY Companion diagnostic regulation is critically challenging biopharma due to Europe's IVDR confusion, uncertainty about LDT reclassification, and fear around upcoming FDA updates. This summer, there’s one essential event to navigate these global regulatory changes, tackle reimbursement and policy issues, reduce submission risks, and ensure timely access to safe and effective companion diagnostics worldwide. Secure your spot in the room now at the World CDx Regulatory Affairs & Policy Summit to make sure you have a role in collaborating with key decision makers, influencing the policies that will shape CDx regulation & reimbursement indefinitely: https://ter.li/j2phi9 Jai Pandey, PhD, Vihanga Pahalawatta, Lori Roadcap, Andrea Renninger, Claudia Dollins Mary J. Savage, Deb Rasmussen, Ralph Riley, Dun Liang, Andrew L'Huillier, Sid Mathur, Qing Li, MD. PhD, Hannah O. Edward, Kaska (Katarzyna) Kowanetz, PhD, RAC, Brian Baker

👉 Let's start the conversation! The FDA's new Final Rule on Laboratory Developed Tests (LDTs) is here, bringing significant changes to the regulatory landscape. Wondering how this affects your lab and what steps to take next?

Here's the second post in our blog series on FDA's recently published LDT rule. We're hoping to make this real for clinical NGS labs who are sorting out how to proceed. Should you pause new test development? Will you have to get FDA clearance for your current LDTs? Probably not, and probably not! Read our post for more.

Strategic selection of tests to develop in your clinical molecular lab is crucial, especially with the FDA's new final rule on laboratory developed tests (LDTs).   At Velsera, we are here to guide you through these changes. Essential areas for learning include: 🔸 FDA Requirements: Understand the new compliance standards for your lab's tests.  🔸 Current and Future Test Offerings: Learn how these regulations impact your ongoing and upcoming test development plans.  🔸 Kitted IVD Solutions: Explore the benefits of FDA-cleared or -approved options versus developing your own tests.  🔸 Exemptions: Find out about specific exemptions and whether they may apply to your lab. Navigating these changes is essential for ensuring your lab's success and continued service to patients and clinicians. We've supported many labs through compliance transitions and are confident we can help you, too. Prepare your lab for the future and ensure you're on the right path. Read the full blog now to stay ahead of the curve and make informed decisions for your molecular lab. https://lnkd.in/ebSGUgXf #MolecularLab #LDT #FDACompliance #ClinicalTesting 

🥁 FDA has officially announced their Final Rule regarding the phaseout of enforcement discretion for laboratory developed tests (LDTs). These tests will now fall under the same enforcement approach as FDA takes with other in vitro diagnostics (IVDs), which FDA believes will better protect the health and safety of patients who rely on the results of LDTs. (The Final Rule will be published in the Federal Register on May 6, 2024, but a PDF version is available leading up to that date.) Check out this blog to find out what's changing and why, stages and what to expect: https://bit.ly/3URWydH #fda #ldt #ivd #finalrule #medtech #greenlightguru #21cfrpart809

#Medtech folks at companies large and small join the FDA's free Annual Industry Conference May 29-30! Wide range of important topics to be delivered by CDRH's top management in the Device Track. Virtual attendance OK! #medicaldevices #medicaldevice

Had an amazing day at the #Medtech summit in Brussels. Was honored to be a panelist on 2 Multi-Stakeholder Panels. 1) Multi-Stakeholder Panel: IVDR & the Transition deadlines. Market withdrawal of IVDs that are unable to meet the IVDR requirements was discussed while highlighting concerns related to essential IVDs supporting patients and clinical studies. 2) Multi-Stakeholder Panel: Certifying Companion Diagnostics. The need for a mechanism in EU to gain guidance on IVD development early on in the development process was a key message in addition to the importance of seeking scientific advice early on in the development process for CDx.

Are you still looking for a comprehensive summary of the IVDR extension proposal? 🤔 No worries, you can still follow our free webinar today at 4pm CEST where our IVD experts will provide the latest updates on the proposed extension and its impact on your daily operations and long-term strategies. 📈 If you would like to attend, you can register here: https://lnkd.in/eVQd4rbT #IVDR #webinar