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Biotechnology | Healthcare | Life Sciences

An FDA Practice With Insider Expertise

Editor: Ms. Gunawardhana, please tell our readers about your background at the FDA. Gunawardhana: I started my career at the FDA in 2003, as a regulatory counsel in the Center for Devices and Radiological Health (CDRH) in the Division of Bioresearch Monitoring within the Office of...

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Healthcare

Former Chief Of DOJ Fraud Unit Discusses Healthcare And FCPA Enforcement

Editor: Please tell us about your background. Walther: I joined Jones Day in January of this year, having spent six years at the Department of Justice. At the DOJ, I served as a line prosecutor, then as a supervisor in the Criminal Division’s Fraud Section. I worked for two years as an...

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Healthcare

The Affordable Care Act As Dissected By A Constitutional Expert

Editor: Is it surprising that the Court failed to uphold the ACA on the basis of the Commerce Clause – the underpinning since the ’30s for upholding broad federal powers? Millett: Surprising? Not really, given the strong jurisprudential support for limiting congressional power on...

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