Trinity WorkingBuildings experts attend FDA's Compounding Quality Conference

I got to hear former FDA commissioner Scott Gottlieb tell #DPHARM2025 attendees the agency is strained by staff losses and slowing policy work — leaving ClinOps teams facing tougher reviews, longer waits, and more uncertainty ahead. Article link in comments #Clinicaltrials #FDA #clinicalresearch Janelle Sabo

An excellent session by Dr. Laurent Natalis (PharmaLex) on Setting Specifications – The Good, the Bad, and the Ugly. Explained how defining product specs is not just about numbers — it’s about balancing clinical relevance, process capability, and regulatory expectations. A great reminder that specs should be data-driven, risk-based, and meaningful for patient safety. #PharmaLex #RegulatoryAffairs #QualityByDesign #CMC #Pharma

Is Your Pharmacy USP <800> Compliant? Compliance with USP <800>, the national standard for handling hazardous drugs, is now required by many states, payors, and accreditors. Pharmacies must implement strict standards for handling hazardous drugs or risk regulatory penalties, PBM audits, and patient safety. Our new article by Cindy Dang, PharmD, JD and Payal Amin, PharmD, RPh, Esq examines the scope and intent of USP <800>, key compliance requirements, and risks of non-compliance. 🛡️ Read more to stay protected: https://lnkd.in/g-7xXvU7 #FrierLevitt #USP800 #HazardousDrugs #PharmacyLaw

With the FDA ending the shortage of GLP-1 medications, pharmacies and providers must now navigate stricter rules around compounding. In her latest blog post, attorney Jillian J. Jewett outlines what qualifies as “essentially a copy,” when compounding is still allowed and how providers can document clinical justifications to remain compliant. Read the full blog ▶https://lnkd.in/eA-ZtRQC

We are pleased to announce that the U.S. Food and Drug Administration (FDA) has issued a favourable response to our 513(g) request, confirming that the upcoming US version of the medidux software qualifies as a low-risk device under enforcement discretion. This determination supports our mission to empower patients and healthcare providers with innovative, user-friendly tools, while ensuring compliance with industry best practices. The FDA response applies to the current functionality of the upcoming US version of the medidux platform

Big news from the FDA! The Food and Drug Administration has expanded its Early Alert Recall Communication Program to cover all medical devices after a successful pilot. This is a major step forward in making recall communication faster, smarter, and safer, and exactly the kind of progress we champion with NotiSphere! Our platform is built to help healthcare providers act quickly and efficiently when recalls happen, protecting patients and streamlining the response process. We’re excited to see this alignment with our mission to bring clarity and speed to medical device recalls. #MedicalDeviceRecalls #PatientSafety #HealthcareInnovation #RecallManagement #PostMarketSurveillance #FDA #HealthcareTechnology #DigitalHealth #SupplyChainInnovation #HealthIT

Excited to see the FDA take this important step — expanding early recall alerts to cover all medical devices. With NotiSphere, we’ve long believed faster, smarter recall communication saves time for providers and protects patients. Great to see the industry moving in this direction!

Even subtle changes in packaging can introduce unexpected impurities into drug products, posing risks to quality and patient safety. In the first case study of our impurity investigation blog series, Nelson Labs Expert Peter Verleyen shares how a contaminant was traced back to a label modification. Thanks to a proprietary in-house spectral database and extensive stock of certified chemicals, our team was able to quickly and confidently identify the impurity. This case demonstrates how even minor packaging changes can affect drug products during their shelf life, and why robust impurity identification strategies are essential. Read the full blog here: https://lnkd.in/dpwWD2ze #DrugDevelopment #QualityControl #ImpurityIdentification #LabTesting #PatientSafety

Here we present our first case study on identification of unexpected impurities in drug products: a small change in secondary packaging leading to a failing impurity test.

Not all “wellness” clinics put patients first. In Toledo, Synergy Primary Care and Wellness lost its license after inspectors uncovered illegal drug sourcing, including Botox bought on Facebook and GLP-1s from an unlicensed facility. Learn more about what they found at https://lnkd.in/gEmXFy_m #MedSpa #Botox #GLP1 #PatientSafety