MoFo Life Sciences

June 30, 2023 - Agtech, European Union, Regulatory
Commission Plans Liberalization of New Genomic Techniques (NGTs) in the EU
By: Wolfgang Schönig
After undergoing an extensive three-year consultation process, the EU Commission’s proposal for a regulation on plants obtained by certain new genomic techniques like CRISPR-Cas (the “Proposal”) is finally available for consideration (see Proposal ). Although the official presentation is scheduled for July 5, 2023,
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June 30, 2023 - Agtech, United States, European Union, Regulatory
The EU’s New Proposal for Plants Developed Using New Genomic Techniques: How Does it Compare to U.S. Regulation?
By: Liz Freeman Rosenzweig Ph.D., Brigid DeCoursey Bondoc and Michael Ward Ph.D.
After much anticipation, the EU Commission’s proposal for a regulation on plants developed using New Genomic Techniques (NGTs) is now under consideration. For an overview of the EU proposal, please see MoFo’s recent post. Here, we provide a brief overview of U.S. regulation of
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June 15, 2023 - AI + Robotics, Digital Health, FDA, Intellectual Property, Medical Devices + Diagnostics, Privacy + Data Security, Regulatory
The Legal and Regulatory Landscape Evolving with AI in Life Sciences
By: Brigid DeCoursey Bondoc and Anna Yuan
Morrison Foerster sponsored and spoke at the Association of Corporate Counsel’s 2023 Life Sciences Conference on May 11, 2023, on the topic of “Artificial Intelligence in Life Sciences: The Evolving Legal and Regulatory Landscape.” Eric Elting of TransPerfect Legal Solutions reported on the discussion.
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May 25, 2023 - Announcements, Healthcare, Regulatory, United States
New York Enacts Material Healthcare Transactions Notice Requirements: Four Key Takeaways
On May 3, 2023, New York Governor Kathy Hochul signed into law an amendment to the New York Public Health Law that will require certain healthcare entities to provide the State Department of Health (DOH) with written notice and supporting documentation of “material transactions”
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May 11, 2023 - AI + Robotics, FDA, Regulatory, Digital Health, United States
FDA on Use of AI/ML in Drug Development: Five Key Takeaways
By: Brigid DeCoursey Bondoc
On Wednesday, May 10, 2023, the Food and Drug Administration (FDA) announced the publication of a new discussion paper titled “ Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products .” The discussion paper aims to facilitate a discussion
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May 03, 2023 - Announcements, Healthcare, Litigation, Regulatory, United States, FDA
FTC Issues Notice of Penalty Offenses on Substantiation of Product Claims
By: Brigid DeCoursey Bondoc and Claudia M. Vetesi
On April 13, 2023, the Federal Trade Commission (FTC) sent approximately 670 notices of penalty offenses to various companies involved in the marketing of OTC drugs, homeopathic products, dietary supplements, and functional foods, placing them on notice that they could incur significant civil penalties
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April 27, 2023 - AI + Robotics, Licensing + Commercial, Regulatory, Intellectual Property
10 Considerations When Licensing AI for Drug Discovery
By: Stephanie Lynn Sharron and Wolfgang Schönig
While the traditional process of discovering a new drug is long and expensive, artificial intelligence drug development platforms can help reduce time and money by efficiently analyzing vast data sets within the drug discovery process. Researchers can use such AI platforms for identifying new
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April 26, 2023 - AI + Robotics, FDA, Medical Devices + Diagnostics, Regulatory, United States
FDA Publishes Draft Guidance for Predetermined Change Control Plan for AI/ML-Enabled Device Software Functions
By: Brigid DeCoursey Bondoc and Brandy A. Guarda
On April 3, 2023, FDA released the draft guidance titled “ Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions ” (hereinafter “draft guidance”) proposing an approach to support iterative improvement through modifications to a machine
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April 25, 2023 - European Union, Regulatory, Pharma, Healthcare, Privacy + Data Security
Key Considerations for Sponsors of Clinical Trials Under the EU Clinical Trial Regulation
By: Robert Grohmann, Alex van der Wolk and Marta Hovanesian
Clinical trials play a crucial role in the development of new medicines and medical devices, but conducting clinical trials involves ethical, legal, and regulatory challenges. As reported in our latest article, Prevent a Clinical Trial from Turning into a Criminal Trial , the United
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March 30, 2023 - COVID-19, FDA, Healthcare, Regulatory, Digital Health, Medical Devices + Diagnostics, United States
FDA Issues Final Transition Guidances for COVID-19 Devices
By: Brigid DeCoursey Bondoc
This week, the U.S. Food & Drug Administration (FDA) issued two much anticipated guidances, each outlining how COVID-19 devices will be treated after the expiration of the COVID-19 public health emergency (PHE) declaration or termination of the COVID-19 Emergency Use Authorization (EUA) declarations: 1)
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Topic Archives: Regulatory

Commission Plans Liberalization of New Genomic Techniques (NGTs) in the EU

By: Wolfgang Schönig

The EU’s New Proposal for Plants Developed Using New Genomic Techniques: How Does it Compare to U.S. Regulation?

By: Liz Freeman Rosenzweig Ph.D., Brigid DeCoursey Bondoc and Michael Ward Ph.D.

The Legal and Regulatory Landscape Evolving with AI in Life Sciences

By: Brigid DeCoursey Bondoc and Anna Yuan

New York Enacts Material Healthcare Transactions Notice Requirements: Four Key Takeaways

FDA on Use of AI/ML in Drug Development: Five Key Takeaways

By: Brigid DeCoursey Bondoc

FTC Issues Notice of Penalty Offenses on Substantiation of Product Claims

By: Brigid DeCoursey Bondoc and Claudia M. Vetesi

10 Considerations When Licensing AI for Drug Discovery

By: Stephanie Lynn Sharron and Wolfgang Schönig

FDA Publishes Draft Guidance for Predetermined Change Control Plan for AI/ML-Enabled Device Software Functions

By: Brigid DeCoursey Bondoc and Brandy A. Guarda

Key Considerations for Sponsors of Clinical Trials Under the EU Clinical Trial Regulation

By: Robert Grohmann, Alex van der Wolk and Marta Hovanesian

FDA Issues Final Transition Guidances for COVID-19 Devices

By: Brigid DeCoursey Bondoc