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Snell & Wilmer Product Liability Group
Experienced trial attorneys. Trusted advisors. Counseling companies across the country and throughout their products' lifecycles.
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FDA Clears Lab-Grown Meat for Human Consumption
The Food and Drug Administration has just indicated that a lab-grown meat product developed by a California start-up is safe for human consumption. “Advancements in cell culture technology are enabling food developers to use animal cells obtained from livestock, poultry, … Continue reading
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FDA Proposes Updated Definition of ‘Healthy’ for Foods
Today, the FDA proposed updated criteria for when foods can be labeled with the nutrient content claim “healthy” on their packaging. This proposed rule would align the definition of the “healthy” claim with current nutrition science, the updated Nutrition Facts … Continue reading
FDA publishes manual on complex product classification for generic development
The US Food and Drug Administration (FDA) recently published a manual of policies and procedures (MAPP) outlining how the Office of Generic Drugs (OGD) will classify which new drugs and drug-device combination products are complex products for generic drug development … Continue reading
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House passes bill to federally decriminalize marijuana
Today, the US House of Representatives to decriminalize marijuana. The House bill, called the Marijuana Opportunity Reinvestment and Expungement Act, or MORE Act, would remove marijuana from the list of scheduled substances and impose a federal tax on marijuana products. … Continue reading
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FDA Approves Second Booster
Yesterday, the FDA authorized a second COVID-19 booster dose for Americans ages 50 and older, along with some immunocompromised individuals, at least four months after their initial booster. The CDC later added its recommendation and said it would include the … Continue reading
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A Deeper Dive into FDA Draft Guidance on the Remanufacturing of Medical Devices
In the medical device industry, there exists a longstanding divide between device manufacturers (i.e., those who design, manufacture, fabricate, or process a finished device) and the third-party entities that service the devices (i.e., those that maintain, restore, refurbish, or repair … Continue reading
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FDA Issues Draft Guidance on Remanufacturing
Yesterday, the FDA published its draft guidance Remanufacturing of Medical Devices to help clarify whether activities performed on devices are likely remanufacturing. The draft guidance includes recommendations as well concerning information that should be included in labeling to help assure the … Continue reading
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| Tagged FDA, life science, manufacturing, Medical Device
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E-Commerce Marketplace Liablity
Can an e-commerce marketplace be liable in a chain of distribution for injury caused by a defective product sold by a third party? This week, the California Court of Appeal, Second District, in Loomis v. Amazon.com LLC, 2021 WL 1608878, … Continue reading
Update on FDA Guidance Pertaining to COVID Variants
As noted, here’s a brief update pertaining to the new and updated guidance for developers of therapeutics, vaccines, and tests for COVID-19. These guidance outline FDA’s vision of a forward-looking, and flexible approach to the evolving nature of the pandemic. … Continue reading
Virginia Legalizes Marijuana
Virginia lawmakers approved a bill this past weekend that would legalize the sale and recreational use of marijuana beginning in 2024. The move makes Virginia the first Southern state to vote to legalize recreational marijuana, joining 15 other states and … Continue reading
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