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The future of cancer detection is bright.

Dr. Alberto Gutierrez will be co-chairing the “Regulatory Strategies for Point-of-Care Diagnostics Special Forum” at the 16th Annual Next Generation Dx Summit in Washington, DC on August 20th. The forum begins with a keynote presentation entitled “Updates on US FDA POC Test Regulations” presented by Timothy Stenzel, MD, PhD, Former Director, Office of in vitro Diagnostics and Radiological Health (FDA). A panel discussion entitled “Regulatory Strategies for Point-of-Care Diagnostics: Learning from Success Stories and Avoiding Pitfalls” and plenary fireside chat entitled “Laboratory-Developed Tests: Proposed Rule, Reclassification Activities, Potential Impact, and Path Forward” feature FDA regulators including Courtney H. Lias, PhD, Acting Director, OHT7: Office of in vitro Diagnostic Devices (FDA), and industry experts. Join the discussion to learn more about the essential components and nuances that are pivotal for regulatory approval for point-of-care diagnostics. #ndapartners #diagnostics #FDA #IVD #LDTs #laboratorydevelopedtests #NGDx #IVDR #regulatorysciences https://lnkd.in/d_z6tMBP.

How is your organization preparing for the IVDR changes? In the rapidly evolving medical landscape, the upcoming deadlines for the new In Vitro Diagnostic Regulation (IVDR) present both challenges and opportunities. The transition to compliance is critical for ensuring your diagnostic applications meet the latest industry standards, paving the way for smoother market access and enhanced patient safety. At TE Connectivity’s Regulatory and Clinical Research organization teams, we understand the complexities involved in navigating these changes. That's why we're offering a free consultation with our seasoned team of experts. Our extensive experience in regulatory affairs and clinical research can provide you with the insights and strategies needed to reduce time to market for your IVDR products. This is an ideal time to review your path to compliance and make any necessary adjustments. By scheduling your free CRO consultation today, you're taking a significant step towards turning upcoming regulatory challenges into strategic advantages. Visit https://lnkd.in/dUYavbvu to book your consultation and begin your seamless transition to IVDR compliance. We’re eager to hear from you. Engage with us in the comments below to share insights and learn from peers navigating the same regulatory landscape.

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

What do you know about the newly developed scientific guidance on drug-drug interaction (DDI) studies? We have all the information about how it affects your #drugdevelopment program – get it here: https://bit.ly/4bbh3Xo #ICHM12 #DrugDrugInteractionGuidance

📌 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. This is a huge change for the labs that make LDTs ‼️ 👀 And while it has been in the works for years, it’s essential that everyone affected understands the fundamentals of the new enforcement framework and how it will impact their work. So in this featured article, we're going to lay out the basics of the rule: what’s changing and how the change will be implemented. Check it out: https://hubs.ly/Q02Dn4QM0 #ldt #laboratorydevelopedtests #ivds #medtech #fda #finalrule #greenlightguru

🥁 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

Colleagues in the LC-MS clinical environment are grappling with the challenges posed by the end of the IVDR transition period. Are you facing similar hurdles? Our upcoming webinar presents a prime opportunity to gain crucial insights and connect with experts who comprehend the entirety of the workflow. Don't let this pivotal moment slip away. Seize the chance to enhance your expertise and overcome the challenges on the horizon. Register now to chart your course to success!