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Welcome to Mofo Life Sciences

MoFo Life Sciences shares timely legal and business insights and in-depth analyses on trends and the complex technologies at the heart of the global pharmaceutical, biotechnology, diagnostics, medical devices, digital health, and AgTech fields.

December 16, 2021 - AI + Robotics, Medical Devices + Diagnostics, Digital Health, Regulatory
AI TRENDS FOR 2022 - FDA REGULATORY
FDA is actively monitoring the use of AI and machine learning (ML) software in medical devices and clinical developments, and has taken a number of first steps in building out a regulatory framework. In 2021, FDA published the AI and Machine Learning Software as
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December 15, 2021 - Global, Agtech, Regulatory
“At any rate, it won’t fail because of money.”
By: Wolfgang Schönig
In an interview with Sabine Wadewitz, life sciences expert Wolfgang Schönig talks about the details of CO²-neutral meat production, the legal framework conditions, and the latest developments in the industry. Excerpt below. _____________________________________________ Dr. Schönig, CO2-neutral meat production is considered one of the key
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November 30, 2021 - United States, FDA, Healthcare
Rescinding the MCIT/R&N Final Rule, CMS Seeks New Approaches for Innovative Technology Coverage
On November 12, 2021, the Centers for Medicare and Medicaid Services (CMS) issued a final rule rescinding the Medicare Coverage of Innovative Technology and Definition of “Reasonable and Necessary” final rule (MCIT/R&N). As we reported in an earlier blog post , CMS first proposed
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November 19, 2021 - FDA
HHS Reverses Policy Prohibiting FDA Review of Lab-Developed Tests
By: Brigid DeCoursey Bondoc
On November 15, 2021, the Department of Health and Human Services (HHS) announced it would reverse a policy issued in August 2020 prohibiting the Food and Drug Administration (FDA) from requiring a premarket review of laboratory developed tests (“LDTs”), including requiring Emergency Use Authorizations
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November 18, 2021 - AI + Robotics, United States, FDA, Digital Health
Three Key Takeaways from FDLI’s Panel Discussion on FDA’s Digital Health Center of Excellence and Working with the FDA in the Digital Health Space
FDLI hosted a virtual conference November 9-10, 2021, titled Digital Health Technology and Regulation During COVID-19 and Beyond. One of the keynote events was the panel on “FDA’s Digital Health Center of Excellence: Working with the FDA on Digital Health.” The panel featured Bakul
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November 16, 2021 - AI + Robotics, United States, FDA, Medical Devices + Diagnostics, Digital Health
Morrison & Foerster Partners Speak at FDLI’s Digital Health Technology and Regulation Conference
The Food and Drug Law Institute (FDLI) hosted the virtual conference Digital Health Technology and Regulation During COVID-19 and Beyond , November 9-10, 2021. Morrison & Foerster’s Stacy Cline Amin and Bethany Hills led panel discussions during the two-day conference. Stacy Cline Amin, who
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November 01, 2021 - United States, FDA, Medical Devices + Diagnostics, Regulatory
FDA and International Counterparts Release Best Practices for Machine Learning in Medical Device Development
This week the U.S. Food and Drug Administration (FDA), along with Health Canada and the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA), identified 10 guiding principles to inform the development of Good Machine Learning Practice (GMLP) and promote safe and effective medical
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November 01, 2021 - Agtech
Alternative Protein - A Comparison of the Regulation of Insect Protein as Food and Feed
By: Simon Arlington
This article follows our introduction to the alternative protein industry and the legal considerations for companies and investors operating within it. The focus of this article is on the regulation of insects as food and feed in the European Union (“EU”), United Kingdom (“UK”),
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October 28, 2021 - United States, Intellectual Property
Traversing Higher Hurdles for Functional Limitations Under Section 112
By: Meghan McLean Poon Ph.D. and Kelsey J. Roberts Kingman Ph.D.
Genus claims have long been an important component of patent strategy, extending coverage around a lead compound to stop would-be competitors. Recent decisions from the Federal Circuit, however, highlight a tightening standard for written description and enablement of genus claims for biologic inventions, leading
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October 26, 2021 - AI + Robotics, United States, FDA, Medical Devices + Diagnostics, Healthcare
Five Key Takeaways from FDA’s Transparency of AI/ML-Enabled Medical Devices Virtual Workshop
On October 14, 2021, the Food and Drug Administration (FDA) held a virtual public workshop on transparency surrounding Artificial Intelligence/Machine Learning (AI/ML) enabled medical devices. The workshop focused on the role of transparency in enhancing the safe and effective use of AI/ML technology in
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Welcome to Mofo Life Sciences

AI TRENDS FOR 2022 - FDA REGULATORY

“At any rate, it won’t fail because of money.”

By: Wolfgang Schönig

Rescinding the MCIT/R&N Final Rule, CMS Seeks New Approaches for Innovative Technology Coverage

HHS Reverses Policy Prohibiting FDA Review of Lab-Developed Tests

By: Brigid DeCoursey Bondoc

Three Key Takeaways from FDLI’s Panel Discussion on FDA’s Digital Health Center of Excellence and Working with the FDA in the Digital Health Space

Morrison & Foerster Partners Speak at FDLI’s Digital Health Technology and Regulation Conference

FDA and International Counterparts Release Best Practices for Machine Learning in Medical Device Development

Alternative Protein - A Comparison of the Regulation of Insect Protein as Food and Feed

By: Simon Arlington

Traversing Higher Hurdles for Functional Limitations Under Section 112

By: Meghan McLean Poon Ph.D. and Kelsey J. Roberts Kingman Ph.D.

Five Key Takeaways from FDA’s Transparency of AI/ML-Enabled Medical Devices Virtual Workshop