2019 FDA Enforcement and Related Litigation Trends (Part 2)

Yesterday, we covered some 2019 stats regarding FDA’s inspections and Warning Letters, and discussed a few specific trends we saw last year. In Part Two of our series, we look at the specifics of FDA’s 2019 consent decrees. FDA Consent Decrees FDA published press releases about …›

October 15, 2019 - CFIUS, Regulatory, United States

Foreign Investment 2020: CFIUS Spotlight on “TID” U.S. Businesses

FIRRMA directed the U.S. Department of the Treasury (“Treasury”), as the chair of CFIUS, to issue regulations that, among other things, address national security concerns arising from foreign investment in U.S. businesses with critical technologies, critical infrastructure, and personal data (referred to in the …›

September 25, 2019 - CFIUS, Regulatory, United States

Foreign Investment 2020: Key Takeaways from the “Modernized” CFIUS Regulations

After more than a year of anticipation, the U.S. Department of the Treasury (“Treasury”) has released proposed regulations to implement the Foreign Investment Risk Review Modernization Act (FIRRMA). These proposed regulations follow an initial round of FIRRMA-implementing regulations issued in October 2018, which most …›

Artificial Intelligence and Pharma

Bethany Hills authored an article for PHARMAnetwork, covering how the pharmaceutical industry has been adopting artificial intelligence and machine learning. Bethany discusses that the pharmaceutical sector has been one of the more robust areas where private partnerships with artificial intelligence-based technology companies have developed. …›

AI Patent Policy – Calling all Life Sciences Practitioners

In the life sciences, artificial intelligence (AI) may be facilitating a sea change in how diseases are diagnosed, prognosed, and treated, and even how therapies are discovered and produced. Indeed, it is possible for AI to provide insights into disease and treatment that could …›