Agency IQ

DECEMBER 1, 2023

What We Expect the FDA to do in December 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. December also typically brings end-of-year perspectives on the agency’s accomplishments.

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Agency IQ

OCTOBER 27, 2023

What We Expect the FDA to do in November 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. There are as many PDUFA dates in November and December as we’ve seen all year.

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Agency IQ

JULY 12, 2024

In response to even more acute drug shortages during the Covid-19 pandemic, the European Commission issued proposals to set up a “European Health Union” meant to address drug shortages in several ways. The non-paper also suggested three potential actions to address drug shortages. Read AgencyIQ’s analysis of the non-paper.]

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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

doi: 10.2210/rcsb_pdb/goodsell-gallery-048 The Virus that Cures It’s been over 25 years since the science magazine Discover first ran an extraordinary article about how a long-forgotten medical treatment, used in the former Soviet country of Georgia, could save us from the growing threat of untreatable, drug-resistant infections.

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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

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

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 court’s opinion was like a bag of stuff you might bring back from a drug store – some goodies and some stuff that might make you embarrassed. The plaintiffs in Acosta-Aguayo v. Walgreen Co. LEXIS 34836 (N.D. The label was not misleading.

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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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