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Biofourmis and HealthXL Report: Digital Endpoint Support for Pharma Label Claims Expected to Become Common Before 2030

An industry report released today forecasts that digital endpoints will see broader adoption in supporting pharmaceutical and life science label claims in the years ahead—but only after industry-wide, pre-competitive collaboration aimed at standardization and proactive sharing of data around clinically validated ...
United States Jaydev Thakkar Value Of Digital Measures In Drug Development Community Strategy For Health Digital Measures Drug Development

Shimmer Research introduces Verisense DHP to provide access to digital health ground-truth sensor data

Shimmer Research, a global leader in wearable technology for research applications, today announced the launch of its Verisense Digital Health Panel (DHP) to provide clinical researchers with access to raw, real-world, digital health ground-truth sensor data.
Geoffrey Gill Shannon Childs Boca Raton Emily Henderson Shimmer Research Schlesinger Group Clinical Division

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Digital endpoints: Global opportunities and clinical, data protection and other challenges

In December, the FDA published a draft guidance providing its recommendations on the use of digital health data acquisition in clinical investigations, signaling that regulatory acceptance of digital endpoints in support of drug approval may occur in the short-term.
United Kingdom Eli Lilly Digital Medicine Society Drug Administration Good Clinical Practices Inspectors Working Group European Medicines Agency

What evidence do you need to board Germany's DiGA Fast-Track?

08:49 AM Digital healthcare regulators, experts and developers discussed the Digital Health Applications (DiGA) process, and yesterday’s (24 Feb) Evidence Con session was designed to help innovators find out more about the new evidence requirements for the assessment of digital products in Germany. The Federal Institute for Drugs and Medical Devices (BfArM) is responsible for the DiGA Fast-Track, which is now up and running. Eleven medical apps to help treat a range of conditions, such as ...
Nordrhein Westfalen Bakul Patel Silvia Schneider Jennifer Goldsack Richard Platt Fda Us Digital Health Center

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