Pharmacy Association of Saskatchewan’s Post

Earlier this week, the FDA alerted healthcare professionals and consumers that several counterfeit Botox cartons were found across several states. Counterfeits not only endanger patients but also erode trust in healthcare. Radio Frequency Identification (RFID) and Near Field Communication (NFC) in drug packaging are part of the Digital Labeling/e-Leaflet Initiative being led by the Axia Institute. Both offer robust solutions to verifying drug legitimacy, writes Swaminathan Subramanian, director of business development for Axia. These connected labels enable real-time tracking and authentication, giving providers and patients the peace of mind to focus on what matters, minimizing those fine lines and wrinkles. Now is the time to safeguard public health and ensure medication integrity. Axia's healthcare consortium is committed to this vital cause. https://lnkd.in/grdKSRF7 #DrugSafety #CounterfeitDrugs #RFID #NFC #ConnectedLabels #HealthcareSecurity #PatientSafety

Focused sessions, interactive discussions, and regulatory updates all here at the 33rd Annual PDA FDA Joint Meeting in Washington DC today. Stop by and chat with our team. How can we help you meet your 2024 goals? #pdafda2024

Last session of the day with a panel discussing 8CPA #pharmacyconnect2024

📣 It is here! The first FDA clearance for patients with atrial fibrillation (AF) and an indication in the category known as “cardiovascular #machinelearning-based notification software” Tempus AI received 510(k) clearance from the FDA for their ECG-AF device that uses #AI to help identify patients who may be at an increased risk of AF. #ai #artificialintelligence #innovation #healthcare #medicine #cardiology #patientcare

📢 📢 Exciting news! FDA has just finalized their LDT guidance, meaning big changes ahead for regulation in the industry. Existing LDTs get a 4-year phase-in period. Ready to dive into the impact? Join the conversation at Executive War College #EWC2024 for insights and strategies to navigate this shift successfully. #LDT #ewc2024 #regulation #industryupdated #FDA https://lnkd.in/gufqAkfP

Check out one of our longtime speakers and keynote contributor to World Orphan Drug Congress USA, Janet Woodcock's thoughts on the industry in a recent Q&A!

Rare Disease breakthroughs are important to everyone! Why’s that? The advances in treatment, or progression management, of rare diseases can provide trailblazing insights for more common ailments. This Virtual Public Meeting also an opportunity for organizations seeking to impact UN SDG3 - Health and Well-Being - because the United Nations Sustainable Development Goals and the 2030 Agenda seem to ensure that “no one is left behind.” No one being left behind requires that we address ALL diseases, no matter how small the patient population might be. The Chiaramello Lab and Mito-EpiGen Program Team will be joining this virtual meeting on Rare Diseases organized by FDA to conclude the Rare Disease Day. We encourage anyone interested in rare diseases, or more mainstream well-being issues, to join this opportunity to share ideas and learn from others. Our founder, Dr. Anne Chiaramello explains, “This is an invaluable opportunity for patients and providers to participate in discussions on clinical trials for rare diseases and on patient engagement at the FDA.” There will be a diverse range of speakers who will discuss topics including clinical research, FDA’s initiatives to advance rare disease medical product development and FDA’s patient engagement efforts. Free continuing education (CE) credit (4.25 hours) is available for eligible health care professionals, as well! In weeks following the Virtual Public Meeting, we will provide ideas about how any business can contribute to tackling rare diseases, to ensure that “no one is left behind.” #mitochondrialdisease #mitochondria #lhonplus #melas #rarediseaseday #rarediseaseday2024 #sdg3 #sdgs #2030agenda #clinicaltrials #innovationinhealth https://lnkd.in/gJcPtQMz

🚨 Just in time: FDA LDT Rule Update 🚨 🇺🇸The White House - Office of Information and Regulatory Affairs (OIRA) has cleared the FDA’s final proposed rule on Laboratory Developed Tests (LDTs). 📖https://lnkd.in/dunXP7yy 👉This pivotal step finalizes the rulemaking process, with publication of the final rule expected imminently, closely mirroring the proposed version. Key Takeaways: 🚀 Immediate Action: FDA to swiftly publish the final rule, enhancing oversight of LDTs and effectively ending enforcement discretion. 🔍 Implications: Expect transformative changes in regulatory compliance for clinical labs operating LDTs and for Life Science Tools and Diagnostic companies, with potential legal challenges to the FDA’s expanded authority. 📅 Don’t miss the DeciBio webinar today where we will discuss the implications of this latest development. #HealthcareRegulation #FDA #LDT #ClinicalLabs #Compliance

working on a new article and losing myself in the regs a bit. the definition of CEHRT in 42 CFR § 495 (PI) and 42 C.F.R. § 414.1305 (MIPS) sorta breaks down to this. for criteria like b9 (care plan), b10 (EHI export), or Drug-drug, drug-allergy interaction checks for CPOE a4 that are not in base EHR and not in either CEHRT definition... what's the lever or incentive to actually implement these?

https://www.fda.gov/. 10 steps to approval: 1. cGMP registered? 2. Product CMC/IND Phase 1 submittal 3. Schedule an FDA inspection 4. Pass, yes! On to phase 2 and 3 5. Did not pass, respond to the FDA 483 Warning Letter. 6. How? Develop a CAPA Table, with CAPA forms, owners and attachments. 7. Schedule a CAPA review meeting 8. Pass, yes! On to phase 2 and 3. 9. IRB review 10. Obtain your BLA Need help with US FDA path to approvals and/or ISO biotech and clean room compliance? www.medregbio.com