Upcoming Webinars
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Wearable and Home-use Devices Part 2: FDA Submissions
In this webinar, Tyler Ting, Director of Regulatory at Rook Quality Systems, walks you through the FDA submission landscape specific to wearable and home-use devices, so you can move from development to clearance with confidence.
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Past Webinars
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Revolutionizing Medicine: The Race to Unlock the Power of Gene Therapy and Build a Competitive Edge
Gene therapies have been the subject of tremendous research and investment in the biotechnology and pharmaceutical fields.
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The Future of Cosmetics Regulation is MoCRA - The Modernization of Cosmetics Regulation Act
For the first time since 1938, the U.S. federal cosmetics regulations have been updated with significant implications for businesses in all sectors of the cosmetics industry. MoCRA aligns the cosmetics regulations with other FDA-regulated areas, including food, drugs, and medical devices while also expanding the FDA’s enforcement powers.
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Transition From COVID-19 Emergency: Demystify the FDA Requirements to Keep Your Device on The Market
Transition From COVID-19 Emergency: Demystify the FDA Requirements to Keep Your Device on The Market This webinar will cover: • What are the main groups of medical devices impacted? • High level: How to go from EUA to traditional submission (EUA guidance doc). • High level: Phased approach to traditional submission – non-EUA (Phased guidance doc). • Legal ramifications: Overview and Prospective.
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Don’t Think You’re a Manufacturer? You Might Be an Apparent Manufacturer: A Look at the Apparent Manufacturer Doctrine
This webinar discusses the Apparent Manufacturer Doctrine under which a nonmanufacturing retailer may be held liable as the manufacturer of a defective product. This doctrine has been ascending in...
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