Healthcare delivery is changing, and digital health is revolutionizing healthcare, creating a burgeoning market opportunity for software-as-a-medical-device (SaMD) and digital therapeutic (DTx) products.
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Find out what Healthcare and Life Sciences businesses and investors anticipate for the healthcare industry in 2022.
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Join us as Tommy Miller, Sr. Counsel and Life Science Lead at Nixon Law Group, speaks with industry experts, John Lazo and Nikki Hastings, about how the global COVID-19 pandemic has impacted pharmaceutical drug development. The panel will discuss how innovators are responding to the pandemic through new tests, devices and therapeutics and how the drug development ecosystem can implement "lessons learned" to help us better prepare for the future of drug discovery.
Welcome to January 2020! I am Tommy Miller, I am Senior Counsel, and life science practice lead here at Nixon Law Group. Today I want to walk you through what I think are the highs and lows of 2019, specifically related to the legislative and regulatory actions taken in the pharmaceutical and medical device space.
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The FDA has just issued four final guidance documents related to the 510(k) clearance applications for medical devices. The Guidance documents can be found here, and they describe the FDA’s current thinking on special 510(k) clearance programs such as the Abbreviated application and the newly established “Special 510(k)” program.
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Following its July 15th letter to Virginia Industrial Hemp Processors (“Processors”) notifying them of Governor Ralph Northam’s recent directive regarding the manufacture of CBD in Virginia, the VDACS Food Safety Program (the “FSP”) sent a letter to Processors on Friday, July 26th setting forth guidelines for Processors to follow when manufacturing cannabidiol (“CBD”) products intended for human consumption (the “Food Safety Letter”).
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The Virginia Department of Agriculture and Consumer Services (“VDACS”) Commissioner Jewel Bronaugh sent a letter (the “July Letter”) to all Virginia-registered Industrial Hemp Processors (“Processors”) on July 15, 2019 notifying the Processors that Governor Northam’s office has directed VDACS to “treat hemp-derived extracts intended for human consumption as approved food additives and to place qualifying Registered Industrial Hemp Processors under food safety inspection so that inspected and approved processors may manufacture a hemp-derived extract for human consumption.”
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The U.S. Food and Drug Administration is currently accepting requests from medical software developers to participate in a precertification pilot program that is scheduled to begin September 1, 2017. The program is aimed at developing precertification criteria for software companies that would allow approved companies to engage in a streamlined premarket review process for certain digital health products. The FDA will accept up to nine participants for the pilot program, which the Agency says will include both large, established software developers and small startup companies.
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