Cereblis’ 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/Q02ynDdD0

In September FDA provided draft guidance on 4 scenarios regarding S&E that would push clinical trials on even non-denovo 510(k) applications.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

Our Step by Step Guide to EUDAMED Registration

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

💊 "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 

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

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

The FDA's long-anticipated final rule, which regulates laboratory-developed tests, appears to have considered concerns regarding the adverse impact on patient care and has outlined several categories of full and partial enforcement discretion. Jane Pine Wood, of our laboratory practice group, has put together an overview of key highlights from the final rule, information on the phase-out process, a timeline for the LDT to IVD transition, and areas of concern for laboratories. #laboratories #FDA #finalrule https://lnkd.in/gmWDW3uH