MoFo Life Sciences

October 15, 2020 - United States, FDA, Regulatory
Bill Proposes Continuation of FDA Rare Pediatric Disease Priority Review Vouchers
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.
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September 30, 2020 - Agtech, Pharma, Regulatory, Asia
China Technology Export Update: Amendment of The Export Technology Catalog
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
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September 23, 2020 - Regulatory, Intellectual Property, Asia
China Patent Linkage Update: Codification and Rulemaking
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 19
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July 22, 2020 - Biotech, Pharma, Regulatory, Asia
China to Criminalize Human Genetic Resources Violations
On June 28, 2020, the draft 11 th 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
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July 10, 2020 - Biotech, Pharma, Regulatory, Asia
China’s Biosecurity Law will cover Human Genetic Resources
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
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March 24, 2020 - COVID-19, European Union, Regulatory, Intellectual Property
Hard Knocks Keep Coming for Europe’s Unified Patent Court
By: Wolfgang Schönig and Robert Grohmann
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
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January 23, 2020 - United States, FDA, Biotech, Healthcare, Pharma, Regulatory
FDA and Real-World Evidence in 2019
By: Keunbong (KB) Do
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
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January 23, 2020 - United States, Agtech, Regulatory, Intellectual Property
Plant Variety Protection Office Now Accepting Applications For Asexually Reproduced Plants
By: Liz Freeman Rosenzweig, Cory Ellison and Michael R. Ward
On January 6, 2020, the Plant Variety Protection Office (PVPO) released the final version of its much-anticipated rule to open Plant Variety Protection (PVP) to asexually reproduced plants. Publication of this rule means that the PVPO is now accepting applications for all species of
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January 15, 2020 - Agtech, European Union, Regulatory
Silver lining? Genome-editing regulation following CRISPR ban in Europe’s Agribusiness
By: Wolfgang Schönig
In its landmark decision of July 25 2018, the Court of Justice of the European Union (“CJEU”) essentially banned crops obtained by new genome editing techniques from the EU market. The decision left the European biotech industry in awe, as it came unexpectedly and
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January 10, 2020 - United States, FDA, Medical Devices + Diagnostics, Litigation, Biotech, Healthcare, Pharma, Regulatory
2019 FDA Enforcement and Related Litigation Trends (Part 3)
Our earlier posts ( part 1 and part 2 ) looked at a few overall trends at FDA as well as the impact of consent decrees issued in 2019. Today we will highlight some enforcement trends at the Department of Justice. Department of Justice
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Topic Archives: Regulatory

Bill Proposes Continuation of FDA Rare Pediatric Disease Priority Review Vouchers

China Technology Export Update: Amendment of The Export Technology Catalog

China Patent Linkage Update: Codification and Rulemaking

China to Criminalize Human Genetic Resources Violations

China’s Biosecurity Law will cover Human Genetic Resources

Hard Knocks Keep Coming for Europe’s Unified Patent Court

By: Wolfgang Schönig and Robert Grohmann

FDA and Real-World Evidence in 2019

By: Keunbong (KB) Do

Plant Variety Protection Office Now Accepting Applications For Asexually Reproduced Plants

By: Liz Freeman Rosenzweig, Cory Ellison and Michael R. Ward

Silver lining? Genome-editing regulation following CRISPR ban in Europe’s Agribusiness

By: Wolfgang Schönig

2019 FDA Enforcement and Related Litigation Trends (Part 3)