MoFo Life Sciences

December 30, 2020 - FDA, COVID-19, Product Liability + Class Action
FDA’s Covid-19 Product Regulation Enforcement Roadmap
By: Erin M. Bosman and Julie Y. Park
Navigating FDA’s regulatory enforcement strategies is paramount to successfully marketing health and medical products for COVID‑19—especially since the pandemic has dominated FDA’s enforcement activity this year. Understanding the patterns and principles behind FDA’s efforts can provide the insight product manufacturers need to avoid FDA
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December 14, 2020 - United States, FDA, COVID-19, Pharma
FDA Authorizes First COVID-19 Vaccine
Late last week, the U.S. Food and Drug Administration issued the first Emergency Use Authorization (EUA) for a COVID-19 vaccine in the United States. The vaccine is manufactured by Pfizer Inc. and BioNTech SE. It consists of two doses taken three weeks apart, and
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December 13, 2020 - United States, FDA
COVID-19: FDA and Compliance Issues with Testing, Vaccines, and Therapies
By: Matthew A. Chivvis and Michael R. Ward
“ We are finally starting to see into the future, understanding the ways COVID-19 is changing the future of FDA regulatory process and advancing innovation to meet the needs of today’s patients. Thanks to all the attendees for such amazing questions and contributions!” commented
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November 23, 2020 - Licensing + Commercial, FDA, COVID-19, Intellectual Property
Podcast: Toward a Therapy for COVID-19: The Science and Legal Considerations
By: Janet Xiao and Michael R. Ward
Researchers around the world are working at record speed to find the best ways to treat and prevent COVID-19. In this last episode of our four-part podcast series, we discuss the science, regulatory framework, and commercial transaction considerations of a COVID-19 therapy. Michael Ward,
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November 20, 2020 - United States, FDA, COVID-19
FDA Authorizes First Full At-Home Test for the Detection of SARS-CoV-2
On November 17, 2020, FDA issued the long-awaited first emergency use authorization (EUA) for a COVID-19 diagnostic test for self-testing at home. The test, the Lucira COVID-19 All‑In‑One Test Kit, can be conducted completely at home by anyone age 14 or over, by collecting
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November 17, 2020 - United States, FDA, Healthcare
Recent Digital Health-Related FDA Announcements
By: Jean Nguyen
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
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November 09, 2020 - Licensing + Commercial, United States, Corporate + Venture Capital, FDA, United Kingdom, Litigation, Startup, Regulatory, Intellectual Property, Announcements
Legal Topics for Scientists, Entrepreneurs, and Start Ups
By: Michael R. Ward, Anita Choi, Andrew Boyd, Alfredo B. D. Silva, Matthew Karlyn, Jim Krenn and Matthew A. Chivvis
The GSAS Harvard Biotech Club and Morrison & Foerster course on Legal Topics for Scientists, Entrepreneurs, and Start Ups features a combination of lectures and interactive workshops and is designed for students, post-docs, entrepreneurs, and investors with life sciences and tech backgrounds to learn
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November 03, 2020 - Licensing + Commercial, FDA, COVID-19, Intellectual Property
Podcast: Toward a Vaccine for COVID-19: The Science and Legal Considerations
By: Otis Littlefield and Michael R. Ward
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:
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October 22, 2020 - 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, Kristen J. Mathews, Matthew Karlyn and Michael R. Ward
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
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October 15, 2020 - United States, FDA, Regulatory
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.
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Topic Archives: FDA

FDA’s Covid-19 Product Regulation Enforcement Roadmap

By: Erin M. Bosman and Julie Y. Park

FDA Authorizes First COVID-19 Vaccine

COVID-19: FDA and Compliance Issues with Testing, Vaccines, and Therapies

By: Matthew A. Chivvis and Michael R. Ward

Podcast: Toward a Therapy for COVID-19: The Science and Legal Considerations

By: Janet Xiao and Michael R. Ward

FDA Authorizes First Full At-Home Test for the Detection of SARS-CoV-2

Recent Digital Health-Related FDA Announcements

By: Jean Nguyen

Legal Topics for Scientists, Entrepreneurs, and Start Ups

By: Michael R. Ward, Anita Choi, Andrew Boyd, Alfredo B. D. Silva, Matthew Karlyn, Jim Krenn and Matthew A. Chivvis

Podcast: Toward a Vaccine for COVID-19: The Science and Legal Considerations

By: Otis Littlefield and Michael R. Ward

Podcast: Applying AI and Data Science to the Fight Against COVID-19: The Science and Legal Considerations

By: Jean Nguyen, Kristen J. Mathews, Matthew Karlyn and Michael R. Ward

Bill Proposes Continuation of FDA Rare Pediatric Disease Priority Review Vouchers