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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.

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
By: Stacy Cline Amin
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
By: Stacy Cline Amin
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, Lip Kian Ang and Julia Kotamäki
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
By: Stacy Cline Amin
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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October 25, 2021 - United States, FDA, Rare Disease, Pharma, Regulatory, Cell + Gene Therapy
FDA Finalizes Guidance on Interpretation of Orphan Drug “Sameness” for Gene Therapy Products
By: Brigid DeCoursey Bondoc
On September 30, 2021, the U.S. Food and Drug Administration (FDA) announced final guidance titled “ Interpreting Sameness of Gene Therapy Products under the Orphan Drug Regulations .” The guidance finalizes the January 2020 draft guidance and provides FDA’s current perspective on certain criteria
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October 13, 2021 - Global, Agtech, Regulatory, Intellectual Property
European Union Adopts Regulation to Extend Term of Community Plant Variety Rights in Europe for Varieties of Certain Plant Species
10/27/2021 Update : The adopted regulation ((EU) 2021/1873) is now officially published in the Journal of the EU. In accordance with the vote of the Council of the European Union on October 5, 2021, the European Union has adopted a new regulation aimed at
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October 08, 2021 - United States, FDA, Litigation, Pharma, Intellectual Property
Skinny Labels Back in Focus after HHS Report on Addressing Drug Prices
By: Fitz B. Collings
Skinny labels are back in focus at the White House. On September 9, 2021, the U.S. Department of Health and Human Services submitted its much-anticipated report to the White House Competition Counsel regarding a “Comprehensive Plan for Addressing High Drug Prices.” The HHS Report—issued
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October 01, 2021 - United States, Healthcare, Privacy + Data Security
Health App and Device Providers Take Note: Health Breach Notification Rule Enforcement Is Coming
By: Melissa M. Crespo
As the mobile health and connected device market continues to grow at an exponential pace, the Federal Trade Commission (“FTC”) has issued a Policy Statement that emphasizes its commitment to ensuring the protection of sensitive information collected by these apps and devices. On September
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Welcome to Mofo Life Sciences

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

By: Stacy Cline Amin

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

By: Stacy Cline Amin

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, Lip Kian Ang and Julia Kotamäki

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

By: Stacy Cline Amin

FDA Finalizes Guidance on Interpretation of Orphan Drug “Sameness” for Gene Therapy Products

By: Brigid DeCoursey Bondoc

European Union Adopts Regulation to Extend Term of Community Plant Variety Rights in Europe for Varieties of Certain Plant Species

Skinny Labels Back in Focus after HHS Report on Addressing Drug Prices

By: Fitz B. Collings

Health App and Device Providers Take Note: Health Breach Notification Rule Enforcement Is Coming

By: Melissa M. Crespo