The U.S. Food and Drug Administration (FDA) recently released a Funding Opportunity Announcement (FOA) to facilitate the development, production, and distribution of pediatric medical devices through the funding of nonprofit consortia. The FOA includes efforts to leverage real-world evidence for regulatory evaluation of medical devices that will foster collaboration between NESTcc and external stakeholders to […]
*Please note that this update extends only to the NESTcc Call for Concepts and is NOT applicable for anyone wishing to submit a response to separate NESTcc opportunities. NESTcc is seeking recommendations from industry for Real-World Evidence test-cases that could be implemented with early data network partners. If you are a medical device manufacturer interested […]
If you are a medical device manufacturer interested in responding to NESTcc’s recently-announced Call for Concepts, we invite you to join us for a live webinar on January 4, 2018 from 3:00p.m. – 4:00p.m. EST. We will use this time to present examples of test-cases, discuss the submission process, and answer your questions. Register Today. […]
Today, NESTcc announced three open opportunities for engagement via the newly-launched www.nestcc.org. The first opportunity—open to medical device manufacturers—is a Call for Concepts for Real-World Evidence (RWE) test-cases to better understand the opportunities and barriers associated with building and maintaining a NESTcc data partner network. The test-case concepts are due January 17, 2018. The next […]
The NESTcc has selected the first-round of Demonstration Projects that address several key use-cases to demonstrate the feasibility and value of generating Real World Evidence for clinical studies across the Total Product Life Cycle. Selected NESTcc Demonstration Projects The selected Demonstration Projects test two approaches to leveraging Real-World Data and generating Real-World Evidence: The first project is […]
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