FDA Updates Digital Health Guidances to Align with 21st Century Cures Act

Source https://www.mintz.com/insights-center/viewpoints/2791/2019-10-fda-updates-digital-health-guidances-align-21st-century On September 26, 2019, FDA released a suite of revised digital health guidances, which includes the following: Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act (“Section 3060 Changes Guidance”) – Final Policy for Device Software Functions and Mobile Medical Applications (“MMA Guidance”) – Final General Wellness: Policy for

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New articles on the ethics of genome editing published in The CRISPR Journal

Source http://www.liebertpub.com/ The CRISPR Journal announces the publication of its October 2019 Special Issue on The Ethics of Human Genome Editing. The Journal is led by Editor-in-Chief Rodolphe Barrangou, PhD (North Carolina State University) and Executive Editor Dr. Kevin Davies. For full-text copies of articles or to arrange interviews with Dr. Barrangou, Dr. Davies, authors, or

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Overcoming the barriers to cell and gene therapies in Europe. BIA and ARM position

By Annie Hubert, Senior Director, European Public Policy at Alliance for Regenerative Medicine ATMPs are varied and complex, ranging from potential one-off curative treatments to treatments tailored to a specific individual. As such, they differ significantly from ‘traditional’ medicinal treatments, something which has been recognised by regulators in Europe: the European Parliament introduced ATMPs as a

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First cell map of developing human liver reveals how blood and immune systems develop

Resource improves understanding of normal development and will support efforts to tackle diseases, such as leukaemia, that can form during early life Source Wellcome Sanger Institute In a world first, scientists have created the human developmental liver cell atlas that provides crucial insights into how the blood and immune systems develop in the foetus. It

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Protective mediators can help heal injured tendon cells by attacking inflammation

Findings reported in The American Journal of Pathology suggest specialized proresolving mediators may become therapeutics that alleviate chronic tendon inflammation Source EurekAlert  Tendon tears, both to the rotator cuff and Achilles heel, are common injuries, especially in aged individuals. Painful and disabling, they can adversely impact quality of life. New approaches are required to help

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NIH Awards $7.5 million to ramp up clinical trials for rare, genetic airway diseases

Formed 15 years ago, the Genetic Disorders of Mucociliary Clearance Consortium is now co-led by UNC’s Stephanie Davis, MD, to continue advancing knowledge and treatments for genetic chronic pulmonary conditions. Source UNC Health Care To continue the push toward clinical trial readiness for individuals with rare diseases, the National Center for Advancing Translational Sciences, in

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Autologous nonmyeloablative hematopoietic stem cell transplantation for neuromyelitis optica

Patients with neurological disease that causes blindness, disability go treatment free Source Northwestern University A stem cell transplant reversed a debilitating neurological disease that causes half of the patients to go blind and lose the ability to walk five years after diagnosis. Most of the patients stayed better five years after the transplant and were

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