MoFo Life Sciences

January 21, 2020 - AI + Robotics, United States, FDA, Medical Devices + Diagnostics, Healthcare
Digital Health in 2019
The year 2019 saw relatively few developments in the digital health space. Although progress has been slow, FDA did make headway on two initiatives: (1) addressing the unique challenges of regulating artificial intelligence and machine learning (AI/ML) in medical applications, and (2) implementing changes
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January 15, 2020 - United States, FDA, Announcements
2020 Under Dr. Stephen Hahn, FDA’s New Commissioner
By: Julie Y. Park
Last month, Dr. Stephen Hahn was officially sworn in as the new commissioner of the U.S. Food and Drug Administration (FDA). The Senate confirmed him by a 73-17 vote. Hahn became the fourth leader of FDA in 2019 and the first confirmed nominee since
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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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January 09, 2020 - United States, FDA, Medical Devices + Diagnostics, Litigation, Biotech, Healthcare, Pharma, Regulatory
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
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January 08, 2020 - United States, FDA, Medical Devices + Diagnostics, Litigation, Biotech, Healthcare, Pharma, Regulatory
2019 FDA Enforcement and Related Litigation Trends (Part 1)
The year 2019 was one of uncertainty for FDA, as former Commissioner Scott Gottlieb announced his departure in March, ultimately stepping down in April. For the bulk of the year, FDA was led by Acting Commissioner, Ned Sharpless, until Brett Giroir took over in
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December 09, 2019 - United States, Litigation, Pharma, Intellectual Property
Striking the Balance in Trade Secret and Corporate Espionage Disputes
By: Matthew A. Chivvis
In 2017, the Commission on the Theft of American Intellectual Property issued a report to Congress estimating that the theft of trade secrets could cost the United States economy as much as $600 billion annually. In the years following, news reports indicate that alleged
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November 22, 2019 - United States, FDA, Litigation, Biotech, Healthcare, Pharma, Regulatory, Intellectual Property
FDA Approves 25th Biosimilar
On November 15, Pfizer’s adalimumab product became the 25th biosimilar approved by FDA under the Biologics Price Competition and Innovation Act (BPCIA). The road to the 25th approval has been long and has involved some of the biggest companies and medications in the pharmaceutical
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October 15, 2019 - United States, CFIUS, Regulatory
Foreign Investment 2020: CFIUS Spotlight on “TID” U.S. Businesses
By: Nicholas J. Spiliotes, Charles L. Capito and Joseph A. Benkert
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
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September 25, 2019 - United States, CFIUS, Regulatory
Foreign Investment 2020: Key Takeaways from the “Modernized” CFIUS Regulations
By: Nicholas J. Spiliotes, Joseph A. Benkert and Charles L. Capito
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
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September 19, 2019 - AI + Robotics, United States, FDA, Product Liability + Class Action, Pharma, Regulatory, Data Analytics
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
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Topic Archives: United States

Digital Health in 2019

2020 Under Dr. Stephen Hahn, FDA’s New Commissioner

By: Julie Y. Park

2019 FDA Enforcement and Related Litigation Trends (Part 3)

2019 FDA Enforcement and Related Litigation Trends (Part 2)

2019 FDA Enforcement and Related Litigation Trends (Part 1)

Striking the Balance in Trade Secret and Corporate Espionage Disputes

By: Matthew A. Chivvis

FDA Approves 25th Biosimilar

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

By: Nicholas J. Spiliotes, Charles L. Capito and Joseph A. Benkert

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

By: Nicholas J. Spiliotes, Joseph A. Benkert and Charles L. Capito

Artificial Intelligence and Pharma