Jon Nygaard

Jon Nygaard

Wilson Sonsini Goodrich & Rosati

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FDA Issues Draft Guidance on "Deciding When to Submit a 510(k) for a Change to an Existing Medical Device"

On August 8, 2016, the U.S. Food and Drug Administration (FDA) issued draft guidance on the important topic of deciding when to submit a new 510(k) premarket notification application (510(k)) for a change to an existing...more

8/19/2016 - Draft Guidance FDA Medical Devices Premarket Approval Applications

Federal Government Continues to Bring Actions Against Pharmaceutical and Medical Device Companies and Individuals for Alleged...

The Office of Inspector General (OIG) for the Department of Health and Human Services recently released its Semiannual Report to Congress. Through the first three quarters of 2015, OIG announced recoveries of $3.35 billion...more

12/18/2015 - Enforcement Actions FDA Medical Devices Misbranding OIG Pharmaceutical Industry

The Life Sciences Report - Spring 2013

In this issue: - Best Patent Practices Under the America Invents Act - CMS Issues Final Rule for Implementing Sunshine Act - New IP Litigation Team a Boon for Firm's Life Sciences and Technology...more

6/12/2013 - America Invents Act Civil Monetary Penalty CMS Final Rules Mayo Foundation for Medical Ed Mayo v. Prometheus Patent Reform Patents Sunshine Act Venture Capital

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