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FDA’s Breakthrough Device Program: Opportunities and Challenges for Device Developers

As part of the 21st Century Cures Act, Congress gave the US Food and Drug Administration (FDA) the authority to establish a Breakthrough Devices Program intended to expedite the development and prioritize the review of certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating disease or conditions. In December 2018, FDA issued a guidance document describing policies FDA intends to use to implement the Program. There are two criteria for inclusion in the Breakthrough Device Program: The device must provide for a more effective treatment or diagnosis of a life-threatening or irreversibly debilitating human disease or condition; and The device must (i) represent breakthrough technology, (ii) have no approved or cleared alternatives, (iii) offer significant advantages over existing approved or cleared alternatives, or (iv) demonstrate that its availability is in the best interest of patients....

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UPCOMING WEBINAR | Digital Health: The New Dynamics — Big Data Part I: Data-Driven Life Sciences Innovation, Personalized Medicine and Research

Health care and life sciences companies increasingly operate in a digital environment. McDermott Will & Emery is hosting a complimentary four-part webinar series to explore the practical business considerations and to simplify the regulatory complexity of digital health, including health information technology (IT), big data, mobile health and telehealth. WEBINAR TWO Big Data Part I: Data-Driven Life Sciences Innovation, Personalized Medicine and Research Date:  Tuesday, December 9 Time: 12:00 – 1:30 pm EST REGISTER HERE Data-driven solutions are a powerful tool for the life sciences sector and research community. This program will explore how life sciences companies, research institutions, providers and informatics businesses can successfully navigate the regulatory landscape for big data to develop, introduce and differentiate products. The following key questions, among others, will be addressed: Overview of Regulatory Framework — How can big data...

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