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 …›

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 …›

MoFo Hosts “Israeli Innovation in Healthcare” Event in Palo Alto

Last week, Morrison & Foerster’s Israel practice hosted a program in our Palo Alto office titled, “Israeli Innovation in Healthcare,” in collaboration with the Israel Economic Mission to the West Coast. The program featured Professor Karen Avraham, Vice Dean of Tel Aviv University’s Faculty …›