FDA and Real-World Evidence in 2019

Around the end of 2018, FDA published the “Framework for FDA’s Real-World Evidence Program” (the “Framework”).[1] The Framework is to provide a basis for the agency in evaluating the potential use of real-world evidence (RWE) in regulatory decisions involving drug and biological products.[2] The …›

Plant Variety Protection Office Now Accepting Applications For Asexually Reproduced Plants

Elizabeth Freeman Rosenzweig, a Morrison & Foerster law clerk in our San Francisco office, Biology PhD, and JD candidate at Berkeley Law, contributed to the writing of this article. On January 6, 2020, the Plant Variety Protection Office (PVPO) released the final version of its …›

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 …›