Recent Digital Health-Related FDA Announcements
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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.
- The U.S. Food and Drug Administration (FDA) is showing its dedication to the advancement of digital health technology with two recent announcements: a new Digital Health Center of Excellence and an update on its Software Precertification Program. Manufacturers developing mobile medical devices, software as... ›
GSAS Harvard Biotech Club and Morrison & Foerster’s New Course
By: Andrew Boyd, Alfredo B. D. Silva, Anita Choi and Michael Ward Ph.D.
MoFo & GSAS Harvard Biotech Club’s new course, “ Legal Topics for Scientists, Entrepreneurs, and Start Ups ,” started on November 11, with more than 100 life sciences graduate students, post-docs, and industry professionals. The Harvard Biotech Club is a student organization that seeks to... ›UK Plans for Robust Life Sciences Regulation Post-Brexit
By: Wolfgang Schönig
As Brexit is finally completed in the UK, from 1 January 2021, the Medicines and Healthcare products Regulatory Agency (“MHRA”) will be the UK’s standalone medicines and medical devices regulator. Transition from the EU allows the UK to offer fully independent regulatory decisions for... ›Podcast: Toward a Vaccine for COVID-19: The Science and Legal Considerations
By: Otis Littlefield Ph.D. and Michael Ward Ph.D.
In this third of a four-part podcast series, we discuss the science, regulatory framework, and commercial transactions considerations of a COVID-19 vaccine. Michael Ward, MoFo partner and global head of the firm’s Life Sciences Group and Patent Group, discusses these issues among others with:... ›- - AI + Robotics, Licensing + Commercial, FDA, COVID-19, Intellectual Property, Privacy + Data Security
Podcast: Applying AI and Data Science to the Fight Against COVID-19: The Science and Legal Considerations
By: Jean Nguyen Ph.D., Matt Karlyn and Michael Ward Ph.D.
In this second of a four-part podcast series on the science, regulatory framework, commercial transactions, and privacy and data security considerations of each unique aspect of the current health crisis, Michael Ward, MoFo partner and global head of the firm’s Life Sciences Group and... › Life Sciences Startup: Top Things to Keep in Mind About Formation and License Agreements
By: Steve Rowles, Matt Karlyn and Michael Ward Ph.D.
During our fifth Patent Law Course session offered by Morrison & Foerster and GSAS Harvard Biotech Club , Steve Rowles, firmwide co-chair of the Emerging Companies & Venture Capital Group , chair of MoFo’s San Diego Corporate Group, and managing partner of the San... ›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.... ›Podcast: Unpacking the Science and Legal Considerations of COVID-19 Testing
By: Matt Karlyn and Michael Ward Ph.D.
In this first of a four-part podcast series on the science, regulatory framework, commercial transactions, and privacy and data security considerations of each unique aspect of the current health crisis, Michael Ward, MoFo partner and global head of the firm’s Life Sciences Group and... ›Navigating The CRISPR Patent Landscape and Understanding The FDA and its Process
By: Michael Ward Ph.D.
“What can be a better day to talk about the complex CRISPR/Cas9 patent landscape than the big day that the Nobel Prize was awarded to pioneers of this revolutionary technology? The story of the continuing dispute on the fundamental CRISPR/Cas9 patents offers a lot... ›Special Patents and AI with Janet Xiao and Anna Yuan
By: Janet Xiao Ph.D., Anna Yuan and Michael Ward Ph.D.
In this third installment of a six-part Patent Law Course offered by Morrison & Foerster and GSAS Harvard Biotech Club , MoFo partner and head of the firm’s China Life Sciences Group Janet Xiao taught a class on the value, protection, and legal issues involved... ›