EU Borderline and Classification Manual Version 4 Released

A new report finds there are fewer antibacterial medicines in clinical pipelines than just two years ago and relatively few qualify as innovative. https://trib.al/Dc2PU2o

15-18 Sep 2025 was #medicaldevices sterilization standards week at #AAMI. If you didn’t attend, here’s what happening in working group 08 (microbiology methods): -      U.S. national adoption of ISO 11737-3:2023 is still ongoing through public comment period then is expected to get through publication later this year -      ISO 11737-1 is under revision. At ISO we have finished working through comments for CD stage so the next thing is to start working on DIS stage. -      ISO 11737-2 is planned for updating and may be delayed slightly to finish work on ISO 11737-1 first. -      The new work item proposal for recombinant methods in endotoxin testing ISO/NP TS25887 might be converted to a revision of ISO 11737-3 to add recombinant content there instead of as a separate technical specification -      AAMI TIR 52 Environmental monitoring for terminally sterilized health care products is under final 15-day before going to publication. Next step is for the co-chairs (myself and Sopheak Srun) to submit a new work item proposal to make an ISO TS based on this document. -      CR517 gap analysis between ST72:2019 and ISO 11737-3:2023 is out to the working group for review and comment. Once comments are back the working group will probably meet mid November or December to review. -      ST72 was being updated to add detail on recombinant LAL testing and new guidance on pre vs post sterilization endotoxin testing. Based on discussions in the meeting last week, the recombinant content and pre vs post sterilization guidance might be merged with the next version of ISO 11737-3 to focus ST72 on US only content for US/FDA specific content on which devices require endotoxin testing and endotoxin limits. We're early enough in the revision process that could still change.

Revolutionising rare disease pharmacovigilance! Discover how curated real-world data, advanced analytics, and AI are transforming safety monitoring for small, diverse patient populations. It's about quality, not just quantity, to make better safety decisions. https://lnkd.in/e28V2qQi #RareDisease #Pharmacovigilance #RealWorldData #RWD #SafetyMonitoring #AIinHealthcare #HealthcareInnovation

🚨 Last time, we explored Antimicrobial Resistance (AMR). Today, let’s shift focus to Antimicrobial Stewardship (AMS) in hospital settings, a critical strategy to protect patients and preserve antibiotic effectiveness. 🔹 What is AMS? Coordinated interventions to ensure the right drug, dose, route, and duration. 🎯 Goals: • Improve patient outcomes • Reduce resistance, toxicity & C. difficile infections • Optimize resources & lower costs ⚠️ Why it matters: ~20% of patients experience adverse effects from antimicrobials, including resistance, drug toxicity, and long-term microbiome disruption. 💡 Core Principles: • Start empiric therapy promptly, then tailor • Reassess at 48–72h (“antibiotic time-out”) • Early IV-to-oral switch • Shortest effective duration • PK monitoring for high-risk drugs 🏥 Building a Stewardship Program (CDC Core Elements): Leadership • Accountability • Pharmacy expertise • Action • Tracking • Reporting • Education 👉 Bottom line: AMS isn’t about restricting antibiotics—it’s about using them wisely to save lives today and preserve their power for tomorrow. #AntimicrobialStewardship #AMR #PatientSafety #ClinicalPharmacy #HealthcareExcellence

Drug–drug interactions (DDIs) are a major, preventable cause of patient harm. A national study in Jordan highlights significant differences between hospital and community pharmacists in DDI knowledge and practices, emphasizing the need for tailored strategies—enhancing interprofessional collaboration in hospitals and improving access to patient data in community pharmacies. Read "Drug–Drug Interaction Management Among Pharmacists in Jordan: A National Comparative Survey" by Derar H. Abdel-Qader et al. 🔗 https://lnkd.in/d6gvPEq6 #drugdruginteractions #pharmacists #patientsafety #polypharmacy #hospitalpharmacy #communitypharmacy

Transform Wound Care with Wound Hygiene! 🩹🦠 Hard-to-heal wounds are everywhere.. 2–6 % of people are affected and up to half of hospital beds are occupied by wound patients. An international consensus recommends a four‑step strategy: Cleanse ➡️ Debride ➡️ Refashion ➡️ Dress. Assuming biofilm in every chronic wound and disrupting it with regular debridement nearly doubles healing rates. Implement wound hygiene at every dressing change and watch your patients heal faster! More insights in my latest review—link in bio! 💬 🔗 Link to 📰 Continuum Series at Medium in Bio 👍🏼 Like, 🚀 Share with Colleagues, ♻️ Repost #WoundCareInnovation #Biologics #SAWC2023 #WoundCare #Biofilm #AdvancingWoundCare #XSONXGuy #ForwardThinking #RaisingTheStandard #debridement #FluorescentImaging #MolecuLightGuy #eleven11continuum

🔬💊 Clinical Trial Phases – Building Trust in Medicines We Use Daily Every medicine we take—whether it’s for a headache, diabetes, or heart disease—has gone through a long and rigorous process called clinical trials before reaching us. These trials ensure that what we consume is safe, effective, and trustworthy. 🌿 Phases of Clinical Trials: 1️⃣ Preclinical Research (Before Human Trials) ✔️ Testing on cells & animals ✔️ Checks safety and biological activity 2️⃣ Phase I (Safety First) 👩⚕️ Small group of healthy volunteers 👀 Evaluates safety, dosage, and side effects 3️⃣ Phase II (Does it Work?) 🧑🤝🧑 Hundreds of patients 🔎 Tests effectiveness & further safety checks 4️⃣ Phase III (Large-Scale Proof) 🌍 Thousands of patients across multiple locations ⚖️ Confirms effectiveness, compares with standard treatments, monitors side effects 5️⃣ Phase IV (Post-Marketing Surveillance) 🏥 After approval, medicine is tracked in real-world use 🔐 Ensures long-term safety and effectiveness 💡 Why it matters in daily life? 👉 The painkiller you take, the insulin you inject, or the antibiotics you rely on—all are available today because of these clinical trial phases. 👉 They protect us from unsafe or ineffective treatments. 👉 They build trust in modern medicine, ensuring better health outcomes for everyone. 🌍 Let’s appreciate the rigorous journey behind every pill, injection, or vaccine—it’s science working silently for our health every day. #ClinicalResearch #HealthcareAwareness #ClinicalTrials #Pharmaceuticals #SafetyFirst

PRAC’s July 2025 Update on Agranulocytosis Risk simplifies clozapine monitoring by emphasizing the Absolute Neutrophil Count (ANC) as the primary parameter, replacing the previous dual WBC/ANC tracking method. This shift marks a significant change in managing neutropenia and agranulocytosis risks. 📌 Key Updates: - Treatment thresholds: - General population: ANC ≥ 1,500/mm³ - Benign Ethnic Neutropenia (BEN): ANC ≥ 1,000/mm³ - Monitoring frequency: - Weekly for the first 18 weeks - Monthly up to 1 year - Every 12 weeks after one year - Annual monitoring after 2 years of stable treatment Data from 26,000+ patients reveals that the risk of agranulocytosis peaks at week 9, diminishing significantly after 2 years, validating the effectiveness of this streamlined monitoring approach. 💡 This shift represents a crucial advancement in maintaining patient safety while enhancing clinical efficiency. It underscores the impact of real-world evidence on reshaping regulatory protocols. 📣 Join the conversation: How do you foresee these updates influencing your monitoring and risk communication strategies? #Pharmacovigilance #Clozapine #PRAC #Agranulocytosis #RegulatoryUpdates #PatientSafety #PVLeadership #LinkedInForPharma

The Silent Threat in Healthcare: Adverse Drug Reactions—and How DNA Can Stop Them In the complex world of healthcare, one hidden threat continues to challenge providers and patients alike: Adverse Drug Reactions (ADRs). Often overlooked, ADRs are a leading cause of preventable harm, taking an immense toll—both human and financial—on our healthcare systems. The Scope of the Problem Did you know ADRs account for over 1.3 million emergency department visits and 350,000 hospitalizations each year in the U.S.? According to the FDA, ADRs represent up to 7% of all hospital admissions and cost the U.S. healthcare system more than $30 billion annually. Beyond finances, the emotional and psychological impact on patients and families is immeasurable. A Smarter Approach: Pharmacogenomics The future of drug safety isn’t luck or trial-and-error—it’s DNA-guided prescribing. Pharmacogenomic testing analyzes each patient’s genetic profile to predict drug responses, minimize ADR risk, and enable truly personalized care. Our precision health platform empowers nutrition experts, wellness professionals, and clinical prescribers to make evidence-based decisions—resulting in fewer medication-related complications, reduced liability, and a lower burden on overstretched healthcare systems. For payers and providers, it’s not just safer—it’s smarter: improved patient outcomes, significant ROI, and full HIPAA compliance. The Future Is Precision Forward-thinking care teams are embracing pharmacogenomics as an essential tool in modern practice. As precision health becomes standard, the era of “one-size-fits-all” prescribing is ending, and safer, more effective healthcare is within reach. How is your organization addressing ADR risks? Let’s start a conversation about moving from reactive care to proactive, precision-driven solutions. #PatientSafety #Pharmacogenomics #PrecisionMedicine #HealthcareInnovation #Genomics #WellnessProviders #PatientOutcomes #FutureofHealthcare #ScylexLab Sources: FDA, CDC, National Institutes of Health

🚀 Bringing Rapid UTI Diagnostics to the Point of Care Did you know that Utilizer-ID will be the first approved culture-based UTI test designed for primary care and near-patient settings—not just the microbiology lab? With its unique built-in software, Utilizer-ID delivers results that are fast, clear, and require no expert interpretation. 🔹 Culture-based results in just 5–8 hours (vs. the usual 1–3 days) 🔹 Point-of-care ready — suitable for primary care clinics and urgent care sites 🔹 Supports antibiotic stewardship with evidence-based treatment decisions the same day By moving reliable diagnostics closer to the patient, we can reduce delays, cut down on unnecessary antibiotics, and take a real step forward in the fight against antimicrobial resistance. 👉 Utilizer-ID is here to transform UTI management at the point of care. #PointOfCare #UTIDiagnostics #AntibioticStewardship #HealthcareInnovation #PrimaryCare #RapidTesting #AMR #Diagnostics #PatientCare #ClinicalInnovation #Utilizer