Cloudbyz’s Post

Learn how the Cloudbyz Vet eClinical Platform aligns with the latest FDA guidelines https://hubs.li/Q02ynCmR0

Learn how the Cloudbyz Vet eClinical Platform aligns with the latest FDA guidelines https://hubs.li/Q02ynCgL0

In September FDA provided draft guidance on 4 scenarios regarding S&E that would push clinical trials on even non-denovo 510(k) applications. Some of its fairly obvious to see, while the latter two scenarios in Section V (and beyond) are ambiguously suggesting that many fungible, recalled, or devices shown to have safety issues, etc, as predicates, may be subject trials. Hmmm… while ambiguity may be held against the drafter in contract law, it usually means different things when authored by FDA. VENTSAFE MEDICAL is prepared to be the regulatory benchmark to show some of the unknown safety issues and validate those that have been academically observed in a head to head trial against conventional ventilators in animal and man.

Did you know that clinical trials don’t stop after a drug is approved? The 'consult your doctor' note on medication packaging is a part of ongoing post-marketing surveillance that ensures safety and effectiveness in real-world use. This is a reminder of the continuous efforts in healthcare to prioritize patient safety and improve outcomes. Stay informed, stay safe! #xceneresearch #clinicaltrials #patientsafety #pharmacovigilance #healthcareinnovation #continuousimprovement

Is an accelerated pathway the right choice for your product? At NDA, we know how crucial a well-planned and executed regulatory strategy is for a collaborative and rapid review, approval and introduction of a new treatment to the patients that need it. Contact us to discuss how our team can help you make the right choice. #ndagroup #medicine #approval #accelerationstrategies #regulatoryaffairs

My presentation for the world of pharmacy: ‘Drug Development: A Beginner’s Guide.’ #pharmacy #drugdevelopment #drugdiscovery #drugsafety #medicine #makingmedicine 💊🩻🏥♥️

Our Step by Step Guide to EUDAMED Registration

💊 "An Adverse Drug Event Almost Took My Life" – A powerful patient story, by one of our very own patient partners, Glen Metcalf, that emphasizes the critical need for increased awareness and reporting of drug reactions. By sharing his experience, Glen highlights the importance of ongoing research in preventing adverse drug events and improving patient safety.   Read the full story on VCHRI’s Newsletter: https://lnkd.in/duhCuFdf   #ActionADE #PatientSafety #AdverseDrugEvents #HealthcareResearch #Pharmacovigilance #HealthCareInnovation #MedicalResearch 

Streamlining your SAE workflows can significantly enhance patient outcomes. Learn actionable strategies in our webinar featuring Rebecca Noss on January 30th. Secure your spot now! https://hubs.li/Q033cDtz0 #ClinicalSafety #SAEWorkflows #Pharmacovigilance

Only 4 Days Left! 🌟 We’re getting closer to #MedSafetyWeek 2024, a global campaign to promote safe medication use and report adverse drug reactions (ADRs). Join us as we share strategies, tools, and insights with experts from NAFDAC, healthcare providers, and pharmacovigilance leaders. Medication safety is a shared responsibility. Let’s make every report count! #MedSafetyWeek2024 #Pharmacovigilance #PatientSafety #NovateFoundation #JoinTheMovement