Ilisa Bernstein’s Post

🚨 Updates from the PDG and FDA Joint Public Meeting on the DSCSA stabilization period! 🚨 Big topics on the table: the FDA’s recent 2-year DSCSA exemption for small dispensers and the fast-approaching stabilization period deadline. Matthew Price, Board Chair at Partnership for DSCSA Governance (PDG) shared some insights. He stated that data exchange is up and we’re heading in the right direction, however, “we still have work to do … we’re not stabilized, and we still have a lot to do in 5 months.” Are you on track for stabilization? Don’t wait! Reach out today to discover how our industry-leading #OneScan solution can keep you #DSCSA compliant in the coming months. Let's get this done together! https://hubs.la/Q02C6Tzd0.

Hey, everyone! Darren Reeves here, President of DP Distribution & Consulting, LLC®, back with another DP Minute. Did you know that when they drafted the QMSR about two years ago, they published it for us to comment on? Fast forward to February, when the final rule was published with what they call the preamble. This preamble includes 83 different comments that the FDA addresses, and we're going to dive into many of them over the next several weeks. Watch the video below to hear Darren summarize the different categories of comments, and begin addressing some of the responses given in the preamble to those questions or requests for clarification. Stay tuned for more insights into these topics. Whether you're a visual learner or just want to stay ahead of the curve, this series is for you. Engage with us here on LinkedIn or visit dpdconline.com to join the discussion. Let's stay informed and navigate the regulatory landscape together!  #QMSR #FDA #MedicalDeviceRegulation #ISO13485 #DPDistributionandConsulting #DPMinute #MedicalDeviceManufacturing #DPDC #MedicalDeviceRegulatoryConsulting 

Here are the different types of categories for the 83 QMSR comments...

Join our webinar to learn how Verisk's Second Look can help reduce WCMSAs. Verisk’s Mark Popolizio, J.D., VP, MSP Compliance, Sid Wong, J.D., VP, Policy and Angela Wolfe, J.D., VP, QA & Training Solutions, host CMS Amended Review – Reduce WCMSAs and get claims settled with Verisk’s Second Look. 🗓️ May 1 ⏰ 2 PM EDT Learn how to navigate CMS’s Amended Review process to reduce prior WCMSAs approvals to get claims settled. Register now: https://ow.ly/VBA930sBQh4 #CMS #FutureAllocations #MSA #WCMSA #Medicare #Verisk #AmendedReview

Stay informed with the latest in healthcare regulatory compliance! Verisys' February 2024 update covers critical topics like DEA regulations, Licensure Compacts, legislative changes, and Board updates, ensuring your organization remains ahead of the curve. Dive into the details and ensure your compliance strategy is robust and up-to-date. Read the full update here: https://hubs.ly/Q02kv0l10 #HealthcareCompliance #RegulatoryUpdates #Verisys

There's still time to register for today's #webinar at 2:00 pm ET. Key takeaways include reviewing the legal basis for #MSAs and the #CMS submission process, examining how non-submit MSAs are a reasonable consideration of #Medicare's interests and exploring the various types and components of non-submit MSAs. https://lnkd.in/gZxcD6MP. #MSPcompliance #MedicareSetAsides #MedicareCompliance

FDA and CMS issued a joint statement affirming FDA's authority to regulate LDTs. This comes at an interesting timing, after the industry submitted many comments re: FDA's proposed rules on LDTs, issued in Sept. 2023. The agencies make it very clear that expanding CLIA regarding LDTs "makes no sense," and that CLIA "is separate in scope and purpose from FDA oversight." If you recall, it was just 3.5 years ago in Aug. 2020 that HHS revoked FDA's authority to regulate LDTs. HHS then reversed this in 2021 and now, the agencies make it very clear that FDA can regulate LDTs. Policies that change so frequently can be confusing for the industry, and it is difficult for the industry to know what to follow and how. It would be helpful for the agencies to engage in in-depth discussions with the industry, then propose a direction and policies that the stakeholders can rely on and comply with. https://lnkd.in/egp_3sM4 "Some have suggested that concerns with LDTs should be addressed through expansion of CLIA. This is not the answer. As was stated in our 2015 testimony, CMS does not have the expertise to assure that tests work; the FDA does. Moreover, establishing a duplicative system for the oversight of tests by expanding CLIA would create more government bureaucracy and inconsistencies. That makes no sense."  (emphasis added) "[W]e are – together – reiterating that CMS’s CLIA program is separate in scope and purpose from FDA oversight." (emphasis added)

Join our webinar to learn how Verisk's Second Look can help reduce WCMSAs. Verisk’s Mark Popolizio, J.D., VP, MSP Compliance, Sid Wong, J.D., VP, Policy and Angela Wolfe, J.D., VP, QA & Training Solutions, host CMS Amended Review – Reduce WCMSAs and get claims settled with Verisk’s Second Look. 🗓️ May 1 ⏰ 2 PM EDT Learn how to navigate CMS’s Amended Review process to reduce prior WCMSAs approvals to get claims settled. Register now: https://ow.ly/a3Wn30sBOw2 #CMS #FutureAllocations #MSA #WCMSA #Medicare #Verisk #AmendedReview

Join our webinar to learn how Verisk's Second Look can help reduce WCMSAs. Verisk’s Mark Popolizio, J.D., VP, MSP Compliance, Sid Wong, J.D., VP, Policy and Angela Wolfe, J.D., VP, QA & Training Solutions, host CMS Amended Review – Reduce WCMSAs and get claims settled with Verisk’s Second Look. 🗓️ May 1 ⏰ 2 PM EDT Learn how to navigate CMS’s Amended Review process to reduce prior WCMSAs approvals to get claims settled. Register now: https://ow.ly/ZOGc30sBUEa #CMS #FutureAllocations #MSA #WCMSA #Medicare #Verisk #AmendedReview

Important Update 🚨The FDA has announced that there will be NO extension to the DSCSA stabilization period. It's crucial to stay ahead of the curve and ensure your compliance with the DSCSA requirements. At VariTec Consulting, we specialize in providing the support and expertise needed to achieve DSCSA compliance efficiently and effectively. Don't wait until it's too late—reach out to us today and let us help you navigate this critical regulatory landscape. #DSCSA #FDACompliance #SerializationSolutions #PharmaceuticalExcellence #ConsultingServices #OptimizeOperations #VariTecConsulting #Healthcare #SupplyChain #Traceability #Compliance #GlobalTeam #ITConsulting #HealthcareIT #SupplyChainManagement #TechSolutions