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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.

October 04, 2022 - FDA, Product Liability + Class Action
Water Is in, White Bread Is Out: “Healthy” Gets a New Look in 2023
By: Claudia M. Vetesi, Lena Gankin and Nick R. Dyess
For decades, health-conscious consumers have argued about what it really means for a food to be “healthy.” Is dark chocolate “healthy”? How about breakfast cereal, coffee, or fruit gummies? At the same time, class action litigants have seized on ever-evolving and subjective definitions of “healthy,” pursuing claims
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September 30, 2022 - United States, Healthcare
A Day Late and a Dollar Short: AAG Polite Warns That Corporate Leaders Who Fail to Invest in Compliance “Early and Often” Do So “At Their Own Risk”
By: Nathaniel R. Mendell, Brian R. Michael, Christine Y. Wong, Kate Driscoll and Mitchell E. Feldman
On September 28, 2022, the Assistant Attorney General for the Criminal Division of the United States Department of Justice (DOJ) joined the Inspector General for the United States Department of Health and Human Services (HHS-OIG) to offer some stern advice for corporate leaders and
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September 28, 2022 - FDA, COVID-19, Healthcare, Medical Devices + Diagnostics, Regulatory, United States
FDA Updates COVID-19 Test Policy
By: Stacy Cline Amin
Brandy Guarda, Regulatory Analyst in Washington, D.C., contributed to the drafting of this post. On September 27, 2022, the U.S. Food and Drug Administration (FDA) updated its COVID-19 Test Policy Guidance to encourage test developers to pursue full marketing authorization as opposed to Emergency
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September 28, 2022 - FDA, Healthcare, Medical Devices + Diagnostics, Regulatory, United States
FDA Releases Foundational Digital Health Guidance
By: Stacy Cline Amin and Brigid DeCoursey Bondoc
On September 27, 2022, the U.S. Food and Drug Administration (FDA) issued its long-awaited final clinical decision support (CDS) software function guidance. This final guidance presents a significant departure from the previous draft version issued three years prior, including updates to address concerns voiced
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September 23, 2022 - Healthcare, FDA, Regulatory, Medical Devices + Diagnostics, United States
New Opportunities for Test Developers: Monkeypox Diagnostics
By: Stacy Cline Amin and Brigid DeCoursey Bondoc
For in vitro diagnostic test developers, the monkeypox public health emergency presents an urgent public health need for testing as well as a unique opportunity for rapid regulatory review of testing products. However, test developers must act fast. The Food and Drug Administration is
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September 13, 2022 - Agtech, United Kingdom, Regulatory
Key Considerations for Early-Stage Companies in the Alternative Protein Industry
By: Simon Arlington
Companies in the UK are regulated by many statutes, ranging from those dictating how much tax they need to pay, to those centred on how they treat their employees. At a corporate level, the main statute that companies should be familiar with is the
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September 12, 2022 - Agtech, Regulatory, United States, Intellectual Property
Purple Tomato Is First Genetically Engineered Plant to Be Deregulated Through USDA’s New Regulatory Status Review Process
By: Liz Freeman Rosenzweig
On September 7, 2022, the United States Department of Agriculture’s Animal and Plant Health Inspection Service (USDA-APHIS) announced the completion of the first Regulatory Status Review (RSR) of a genetically engineered plant under the SECURE rule. APHIS concluded that a new genetically engineered tomato
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September 09, 2022 - AI + Robotics, Intellectual Property, Medical Devices + Diagnostics
The Importance of Patents for ML-Based Medical Device Inventions
By: Christopher Gloria
The use of machine learning (ML) in the medical device field has greatly expanded in recent years, becoming increasingly important to the product offerings of many medical device companies. The benefits provided by ML are wide-ranging and include providing earlier and more accurate diagnoses
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August 29, 2022 - Intellectual Property, Litigation, FDA, Regulatory
Recent Biden Administration Efforts on Drug Pricing: USPTO Notice Focuses on Eliminating Inconsistencies in USPTO/FDA Statements
By: Meghan McLean Poon, Kelsey J. Roberts Kingman and Stacy Cline Amin
On July 29, 2022, the U.S. Patent and Trademark Office (USPTO) issued a Notice in the Federal Register clarifying the duty of disclosure that may keep patent practitioners up at night. The Notice reminds applicants of the duties of disclosure and “reasonable inquiry” for proceedings
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August 26, 2022 - Agtech
Partnering with the Alternative Protein Sector
By: Michael Ward Ph.D.
Originally published on the Future Food-tech Alternative Proteins website. Morrison Foerster recent participated in the Future Food-Tech Alternative Proteins Summit, where investors, brands, and start-ups met to unlock new partnership opportunities and showcase innovation across plant-based, cell-based, and microbial fermentation. Ahead of the summit,
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Welcome to Mofo Life Sciences

Water Is in, White Bread Is Out: “Healthy” Gets a New Look in 2023

By: Claudia M. Vetesi, Lena Gankin and Nick R. Dyess

A Day Late and a Dollar Short: AAG Polite Warns That Corporate Leaders Who Fail to Invest in Compliance “Early and Often” Do So “At Their Own Risk”

By: Nathaniel R. Mendell, Brian R. Michael, Christine Y. Wong, Kate Driscoll and Mitchell E. Feldman

FDA Updates COVID-19 Test Policy

By: Stacy Cline Amin

FDA Releases Foundational Digital Health Guidance

By: Stacy Cline Amin and Brigid DeCoursey Bondoc

New Opportunities for Test Developers: Monkeypox Diagnostics

By: Stacy Cline Amin and Brigid DeCoursey Bondoc

Key Considerations for Early-Stage Companies in the Alternative Protein Industry

By: Simon Arlington

Purple Tomato Is First Genetically Engineered Plant to Be Deregulated Through USDA’s New Regulatory Status Review Process

By: Liz Freeman Rosenzweig

The Importance of Patents for ML-Based Medical Device Inventions

By: Christopher Gloria

Recent Biden Administration Efforts on Drug Pricing: USPTO Notice Focuses on Eliminating Inconsistencies in USPTO/FDA Statements

By: Meghan McLean Poon, Kelsey J. Roberts Kingman and Stacy Cline Amin

Partnering with the Alternative Protein Sector

By: Michael Ward Ph.D.