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OrthoStreams newsletter just dropped today... https://lnkd.in/e6jSYbb Deep technical review of hydroxyapatite and other calcium phosphate containing biocomposites and hybrid biomaterials. Sharing this excellent body of work for the biologics geeks out there. Calcium Orthophosphate (CaPO4) Containing Composites for Biomedical Applications: Formulations, Properties,and Applications Link to publication – https://lnkd.in/eqYrGrax Table 5. A list of several commercial non-setting CaPO4-based IBS and pastes with indication of producer, product name, composition (when available), and form [930]. Producer Product Name […] EtO causes cancer. Device sterilizers are scrambling to find alternatives. EtO causes cancer. Device sterilizers are scrambling to find alternatives. MedTechDive No one solution can match the scope and scale of ethylene oxide, but a “multi-pronged approach” can help reduce emissions, an FDA official said. he Environmental Protection Agency finalized new regulations in March that will enforce tighter regulations on ethylene oxide, one of the most common […] Startup treating knee cartilage defects is finishing out their Series A raise. Early results for these knee cartilage defect patients are impressive in that the patients achieved early weight bearing. website – https://lnkd.in/da6id3G6 SUMMARY: Askel Healthcare, a Finnish medical technology company is presenting early clinical results. The Pilot Trial has 20 patients in total, out of which 19 have now been operated. Askel has now presented a […]

To read How to Make an FDA-Approved Drug, subscribe ~ https://lnkd.in/gvhzRSZM The Investigational Path In the realm of science, a journey begins, With dreams of healing, where hope never dims. A novel compound, unknown and bright, Seeks the dawn of clinical trial light. An IND, the gatekeeper’s call, Preclinical data, ensuring no fall. Pharmacology, toxicology in hand, Safety and promise, a future planned. Trials and Tribulations Through the phases, the drug must tread, From Phase I's safety to efficacy's spread. Volunteers brave, in the name of trust, Hoping this compound’s potential is just. Manufacturing secrets, protocols laid, In meticulous detail, the groundwork is made. For every discovery, a rigorous test, To ensure that patients receive the best. The Abbreviated Quest In the shadows of patents, a new hope wakes, A generic challenger, the market it stakes. An ANDA filed, not seeking to claim, But to mirror the original, in essence and name. Bioequivalence, the banner unfurled, Proving sameness in a different world. No need for trials from the start, But quality and performance play their part. The Pathways Converge Two roads in the drug approval land, Each with a goal, unique in hand. One brings innovation, fresh and new, The other ensures access, for the many, not few. INDs light the path where pioneers roam, ANDAs follow, giving treatments a home. Together they dance in the pharmaceutical sky, Bringing relief to where suffering lies. Subscribe with the link below ~ https://lnkd.in/gvhzRSZM

Going out, tomorrow (Sunday) and Monday — we get into the basics of How to Make an FDA-Approved Drug In our two-part series, we explore what it means to reclaim ownership of our health by demystifying the complex landscape of pharmaceuticals and clinical trials. Part I (Sunday, 3pm Pacific Time) We start with a poem that you can read now at the Enthereal page now, followed by a beginner’s guide to navigating the pharmaceutical approval process. This includes an inside look at the clinical trial system, the distinction between INDs and ANDAs, and we'll take a look at a vision of the growing trend around using consumer data as evidence in clinical trials. We also dive into the legal and ethical concerns that arise—and practical steps for addressing them. Part II (Monday, 3pm Pacific Time) Building on that foundation, we examine the roles traditionally involved in clinical trials and the unique dynamics of a community-led approach. We then compare the conventional clinical trial structure with an alternative, community-driven model, and distill the essential elements needed for a successful clinical trial process. Together, these posts provide a roadmap for exploring the more conscious engagement with collaborative ownership of our healthcare systems. #letsgetreal #enthereal

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