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What is M-E-A-T?

M-E-A-T has become a complicated word. A variety of alternative meat products are on the market or in development. Plant-based meat substitutes are already commonplace in our grocery stores and restaurants. Some of these...more

Legal Challenge to the FDA’s Approval of “Blood” in Plant-Based Meat

By now, most of us have seen plant-based “meat” in supermarkets and restaurants. For one of those plant-based meat substitutes, ImpossibleTM Burger, a lawsuit is underway challenging the FDA’s approval of the compound used to...more

Using Viruses to Prevent Foodborne Illness

Food poisoning is an experience that no one is likely to ever forget. Some of the common bacteria that cause foodborne illness include Listeria monocytogenes (L. monocytogenes), Salmonella (S. enterica), and Escherichia coli...more

An Untapped Natural Treasure Trove of Viruses to Treat Drug-Resistant Bacterial Infections

Phages, formally called bacteriophages — the most abundant, ubiquitous organisms in nature — are viruses that infect, replicate in, and destroy bacteria. These viruses are species-specific, and sometimes infect only certain...more

Emergency Use Authorization Issued for COVID-19 Antibody

On November, 10, 2020, the US Food and Drug Administration (FDA) granted an Emergency Use Authorization (EUA) for the investigational neutralizing antibody bamlanivimab (Eli Lilly and Company, Indianapolis, IN) for the...more

Let the record reflect –Are you keeping the records required by the FSMA Produce Safety Rule?

As part of the Food Safety Modernization Act (FSMA), the Produce Safety Rule outlines the regulatory requirements that apply to entities that grow, harvest, pack or hold fresh produce. Depending upon the amount of their...more

Where there is smoke, there is fire, or is there?

When you buy and eat smoked nuts and cheeses, do you have images of smoke from a wood fire wafting up from smokers as you savor those snacks? Have you ever thought about how your nuts and cheeses were smoked? Many of those...more

New blood test to guide personalized cancer treatment

On August 26, 2020, the U.S. Food and Drug Administration approved Foundation Medicine, Inc.’s Foundation One® Liquid CDx, a quantitative next-generation sequencing (NGS) test that can detect mutations using circulating...more

Liquid Biopsy and Next-Generation Sequencing Combined: Legal Implications?

The Food and Drug Administration’s approval of Guardant Health’s Guardant360 CDx assay marks a new era for genetic mutation testing in cancer treatment. On August 7, 2020, the FDA approved the first diagnostic test that...more

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