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FDA Issues Draft Guidance on Use of Decentralized Clinical Trials The FDA has published a new draft guidance on the use of decentralized clinical trials (DCT), which it defines as a clinical trial where some or all of the trial-related activities occur at locations other than traditional clinical trial sites. “Decentralized Clinical Trials for …
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Best Practices and Pitfalls When Going from Concept to Commercialization MedTech Internet of things (IoT) start-ups and early-stage innovators often launch with a minimum viable product, or MVP, a version with just enough features and stability to be used in clinical or field-testing. With the right MVP, companies can prove technical feasibility and position …
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Realizing the Promise of Real-World Evidence in MedTech Ever since the U.S. Food and Drug Administration (FDA) enacted the 21st Century Cures Act in 2016 and encouraged sponsors to utilize real-world evidence (RWE) with the intent to increase innovation and accelerate product development, medical technology innovators have been eager to comply. The burgeoning use …
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