FDA Releases Foundational Digital Health Guidance
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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.
- 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... ›
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... ›Key Considerations for Early-Stage Companies in the Alternative Protein Industry
By: Simon Arlington, Julia Kotamäki and Michelle Si-Ting Luo
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... ›Purple Tomato Is First Genetically Engineered Plant to Be Deregulated Through USDA’s New Regulatory Status Review Process
By: Liz Freeman Rosenzweig Ph.D.
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... ›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... ›Recent Biden Administration Efforts on Drug Pricing: USPTO Notice Focuses on Eliminating Inconsistencies in USPTO/FDA Statements
By: Meghan McLean Poon Ph.D., Kelsey J. Roberts Kingman Ph.D. 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... ›- - 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,... › Last Week in the Federal Circuit (August 8 – August 12): Taking a round Trip on the Assignor Estoppel Express
By: Brian R. Matsui
Our Federal Circuitry blog recently discussed the Court's decision in Hologic, Inc. v. Minerva Surgical, Inc. , No. 19-2054. You should read this case if: you want to know how the Federal Circuit will treat assignor estoppel post- Minerva You have to feel a little... ›Last Week in the Federal Circuit (August 15 – August 19): The Court Rebuffs Patent Owner’s Attempt to Read Anda Application in Isolation
By: Brian R. Matsui
Our Federal Circuitry blog recently discussed the Court's decision in Par Pharmaceutical, Inc. v. Eagle Pharmaceuticals, Inc. , No. 21-2342. You should read this case if: you have an ANDA case involving “actual, real-world evidence” that might conflict with what the ANDA says For our... ›- - Agtech
CRISPR’s Next 10 Years: From Lab To Plate?
By: Michael Ward Ph.D. and Sarah E. Bloch Ph.D.
Originally published on the World Agri-tech website. 10 years on from its discovery, CRISPR’s potential for agricultural adaptation has started to gather momentum. In advance of the 2022 World Agri-tech Innovation Summit in London, the industry’s leading specialists weighed in on what new frontiers... ›