Advize’s Post

FDA's Center for Devices and Radiological Health #CDRH has published a new, public dataset to help assist #chemicalcharacterization methods used for the assessment of #medicaldevices. This dataset will allow #analyticalchemistry labs to determine their ability to detect a broad range of potential #chemicals by offering access to their #physicochemical properties and results from #gaschromatography (GC) protocols conducted by CDRH. Read more: https://lnkd.in/gerTHRse Link to dataset: https://lnkd.in/gXtweM79 #medtech #FDAcompliance #Biocompatibility #HealthTech #biologicalsafety #analyticalperformance

With the average cost of a successful drug trial reaching $2.6 billion, every day saved is crucial. Research indicates 80% of trials face delays, emphasizing the need for streamlined processes to reduce time and financial burdens. 📚 Explore cost-saving strategies: https://lnkd.in/gKRrBifB #ClinicalTrialsCost #EfficientResearch #PharmaSols #DrugApproval #HealthEconomics #ResearchIm

Discover new ways to make products safer at the CBTOX 2024 congress in Rio De Janeiro. Letícia Castro will be there representing Sobel as an expert in biological and toxicological assessments to make products safe for patients. At CBTOX 2024, experts will talk about the latest ways to check if products are harmful, and share new ideas that you can use in your own work. Learn important information, proven methods, and the latest research that will change how you make sure products are safe. Need support with your tox assessments? Contact us TODAY! #ToxAssessment #BiologicalEvaluation

Impurities testing requires robust analytical methods for accurate quantification. Here are 3 ways we protect patient health outcomes ➡️ 1. Careful selection of methods to minimize impurities. 2. Draw on expertise with a diverse range of elemental and non-elemental impurities. 3. Employing the Z factor approach to increase confidence. Don’t let analytical challenges or bench space hold you back. Find out more about Sannova’s state-of-the-art impurities testing lab. #pharma #FDA #clinicaltrials #safety #manufacturing

The Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) published an new version of “GUIDELINES on the benefit-risk assessment of the presence of phthalates in certain medical devices covering phthalates which are carcinogenic, mutagenic, toxic to reproduction (CMR) or have endocrine-disrupting (ED) properties” Want to see what has changed in detail? https://lnkd.in/dsNRk3kH Source of the document: https://lnkd.in/dQ8khBuQ All MDCG documents can be found here: https://lnkd.in/eQJ7zvz9 #medicaldevices #astracon #mdcg #mdr #ivdr

FDA Releases New Diversity Action Plan Guidance: Key Insights and Exclusive Analysis for the Life Science Sector

Discover new ways to make products safer at the CBTOX 2024 congress in Rio De Janeiro. Letícia Castro will be there representing Sobel as an expert in biological and toxicological assessments to make products safe for patients. At CBTOX 2024, experts will talk about the latest ways to check if products are harmful, and share new ideas that you can use in your own work. Learn important information, proven methods, and the latest research that will change how you make sure products are safe. Need support with your tox assessments? Contact us TODAY! #ToxAssessment #BiologicalEvaluation

Regulatory requirements concerning #biocompatibility should be considered at every stage of #medicaldevice development. By adopting proactive approaches to #biocompatible material selection, manufacturers can have a high degree of certainty in building safe and effective devices. This article from Jocivania Oliviera da Silva and Marielle Fournier in the #October issue of #RegulatorRapporteur discusses biological evaluation requirements and ways to optimise material selection. Read it online now 👉 https://lnkd.in/eeR5WjQd #RegulatoryRapporteur is our peer-reviewed journal, published online 11 times a year and available free to #TOPRA members. The October edition focuses on #veterinarymedicines and the measures being taken to reflect the new requirements in regulation.

Discover new ways to make products safer at the CBTOX 2024 congress in Rio De Janeiro. Letícia Castro will be there representing Sobel as an expert in biological and toxicological assessments to make products safe for patients. At CBTOX 2024, experts will talk about the latest ways to check if products are harmful, and share new ideas that you can use in your own work. Learn important information, proven methods, and the latest research that will change how you make sure products are safe. Need support with your tox assessments? Contact us TODAY! #ToxAssessment #BiologicalEvaluation #Biocompatability

Kratom Scientists Issue Statement on Regulation: Key Findings Revealed! The statement highlights the most important conclusions from research: • Mitragynine is the major alkaloid in kratom and because of this, it has been the subject of most scientific reports; • Mitragynine is not a classical opioid, like morphine, but rather is unique in that it has partial agonist activity and relatively low abuse liability; • With a diverse kratom product marketplace in the US, it is important to distinguish between products; • In the years that kratom whole leaf and extract products have been sold in the US, there have been, to date, few clinical case reports of adverse effects; By highlighting the distinct characteristics of mitragynine and the limited adverse effects reported from kratom products, it provides a nuanced understanding of the plant’s potential benefits and risks. Moving forward, informed regulatory decisions should consider the scientific evidence presented, ensuring the responsible use and availability of kratom products while prioritizing public safety. https://lnkd.in/gCKw8h6F