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

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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A Deeper Dive into FDA Draft Guidance on the Remanufacturing of Medical Devices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FDA Issues Draft Guidance on Remanufacturing

Yesterday, the FDA published its draft guidance Remanufacturing of Medical Devices to help clarify whether activities performed on devices are likely remanufacturing. The draft guidance includes recommendations as well concerning information that should be included in labeling to help assure the … Continue reading

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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

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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

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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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FDA Releases New Guidance for Covid-19 Products

At the beginning of this week the FDA unveiled four new and updated guidance targeting vaccines, drugs and biologics, monoclonal antibodies and diagnostic tests. to address the impact of COVID-19 variants on the efficacy and performance of their products. In … Continue reading

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