Agency IQ

NOVEMBER 27, 2023

Many posted comments came from professional pharmacy organizations, trade groups like the Pharmaceutical Research and Manufacturers of America (PhRMA) , and pharmaceutical companies, such a Eli Lilly , Novo Nordisk and Merck.

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Agency IQ

JUNE 16, 2023

The 51 regulations that FDA is currently working on The FDA today unveiled its much-anticipated Spring 2023 Unified Agenda, a document outlining the regulations the agency plans to release in 2023 and beyond. The latest update, announced this week, is known as the Spring 2023 Unified Agenda.

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Codon

FEBRUARY 13, 2024

Fast forward to 2023. Phage therapies are sold at a pharmacy in Georgia. 2 As you might imagine, getting packages marked ‘viruses’ through customs is a problem in many countries, requiring special permissions or fees. At least a million people die from drug-resistant bacterial infections every year.

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Agency IQ

AUGUST 25, 2023

BY ALEXANDER GAFFNEY, MS, RACAUG 22, 2023 10:19 PM CDT Regulatory background: How FDA regulates CBD Cannabidiol (CBD), a biologically active chemical compound derived from the Cannabis sativa plant, significantly benefited from the passage of the 2018 Farm Bill. The letter gave respondents until August 18, 2023 to respond to the request.

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Drug & Device Law

DECEMBER 29, 2023

In 2023 there seemed to be an unusually large number of other decisions that are likely to have a substantial impact on what we or our clients do, but involve either different products, non-product claims, or both. In 2023, these include United States ex rel. 2023) (no medical monitoring in Delaware) ( here ); Brown v.

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Drug & Device Law

MARCH 8, 2023

March 2, 2023), visited their friendly neighborhood drug store and bought a lawsuit. The cream product’s packaging was a different size and shape, and its text bullet points and bubbles were different from the patches. Consumers coming into pharmacies without a prescription would not be able to buy any product that is stronger.

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Drug & Device Law

JANUARY 4, 2024

FDA letter , December 14, 2023 (by Peter Marks, director CBER) (emphasis original). The “result” alleged was that “[a]s of November 10, 2023, Texans have been administered almost 30 million. . . 2023) (finding defendant’s vaccine to be a covered countermeasure; preempting all claims), review denied (Kan. 25, 2023); Goins v.

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Drug & Device Law

MAY 15, 2023

2d , 2023 Wisc. May 2, 2023), and M.T. 3d , 2023 WL 3135662 (Kan. April 28, 2023). 2023 WL 3135662, at *3-5 (detailed PREP Act discussion). 2023 WL 3135662, at *1 (quoting complaint). includ[es] retail pharmacies. They are: Gahl v. Aurora Health Care, Inc. LEXIS 137 (Wis. Walmart Stores, Inc. ,

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Drug & Device Law

OCTOBER 25, 2023

Weigh any packaged meat at a grocery store, and there’s a decent chance the weight will be wrong. But every once in a while, a court will see through the consumer fraud case as itself being phony, and will throw the case out as if it was a package of spoiled meat. Colourpop Cosmetics, LLC , 2023 U.S. LEXIS 185688 (N.D.

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