Since the decision of the European Court of Justice (“ECJ”) in the Schrems II case, transfers of personal data from the EU to the United States have been under scrutiny. The ECJ reviewed the situation where personal data are sent from an EU affiliate …›
As Brexit is finally completed in the UK, from 1 January 2021, the Medicines and Healthcare products Regulatory Agency (“MHRA”) will be the UK’s standalone medicines and medical devices regulator. Transition from the EU allows the UK to offer fully independent regulatory decisions for …›
The GSAS Harvard Biotech Club and Morrison & Foerster course on Legal Topics for Scientists, Entrepreneurs, and Start Ups features a combination of lectures and interactive workshops and is designed for students, post-docs, entrepreneurs, and investors with life sciences and tech backgrounds to learn …›
Morrison & Foerster Research Analyst Christine Lentz contributed to the writing of this article. The House of Representatives recently passed a proposed bill that encourages treatments for rare pediatric diseases by prolonging the authority of Health and Human Services to issue priority review vouchers. H.R.4439, …›
On August 28, 2020, China’s Ministry of Commerce (MOFCOM) and Ministry of Science and Technology (MOST) jointly published a notice on the adjustment of China’s Catalog of Technologies the Export of Which is Prohibited or Restricted (the “Catalog”). This is the first time the …›
On July 3, 2020, China’s National People’s Congress published the second draft of the latest amendment to China’s Patent Law (the “Draft Amendment”) for public comments, which were allowed to be submitted by August 16, 2020. The Draft Amendment included proposed revisions to …›
On June 28, 2020, the draft 11th amendment to China’s Criminal Law (the “Draft”) was submitted to the Standing Committee of the National People’s Congress for review. The Draft added a number of crimes intended to “connect” with certain provisions in China’s Human Genetic …›
During its April 2020 meetings, the Standing Committee of China’s National People’s Congress reviewed a number of draft legislations, among which was a draft Biosecurity Law. At the conclusion of the meetings, the second draft of the Biosecurity Law (the “Draft”) was published for …›
With brexited UK announcing that it will not join Europe’s long-awaited Unified Patent Court (UPC), the establishment of an efficient pan-European patent litigation system faces ever‑mounting challenges. Last Friday, the German Federal Constitutional Court declared that the German Act of Approval of the UPC …›
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 …›