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Cortex - Life Sciences Insights

Jae Kim

DLA Piper

About me

19 Feb, 2024

FDA’s new Quality Management System Regulation is here: Key takeaways for device companies in US, EU, and China

By Bethany Hills Christopher Mikson Perham Gorji +4 more...

On January 21, 2024, the FDA issued a final rule amending its Quality System (QS) regulations under 21 CFR Part 820, which addresses...

28 Apr, 2022

What FDA Expects From Medical Device Cybersecurity Efforts

By Jae Kim Raymond M. Williams

This article was first published in Law360 In recent years, the threat of cybersecurity attacks has evolved in the minds of the public...

06 Nov, 2020

The US Hemp Production Handbook

By Stefanie Fogel Jae Kim Christopher Gismondi

Hemp production in the US has soared in the last five years and is expected to continue its high rate of production and growth in the...

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