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.

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Agency IQ

SEPTEMBER 29, 2023

What We Expect the FDA to do in October 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. AgencyIQ October 1 Nitrosamine testing due to FDA.

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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.

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Agency IQ

MARCH 25, 2024

In proposed rule, FDA offers up a (surprisingly sparse) list of drugs that present demonstrable compounding difficulties FDA yesterday released a long-awaited proposed rule on a list of drug products that present demonstrable difficulties for compounding. What is drug compounding?

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FDA Law Blog: Biosimilars

AUGUST 8, 2024

With apologies to Curtis Mayfield) By the close of the public comment period for the Drug Enforcement Administration’s (“DEA’s”) proposal to reschedule marijuana two weeks ago, the agency had received over 43,500 comments. Schedule I substances have a high potential for abuse, no currently accepted medical use in treatment in the U.S.,

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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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Drug & Device Law

MAY 19, 2023

Over the past few months, Bexis, with the substantial help of several Reed Smith associates, has prepared a law review article – “Federal Preemption and the Post- Dobbs Reproductive Freedom Frontier” – which will soon be published in the Food & Drug Law Journal. Sorsaia , 2023 WL 3211847 (S.D.W. Sorsaia , 2023 WL 3211847, at *2.

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Drug & Device Law

JULY 24, 2023

2019) (“ PATDC82 I ”), because the third-party payor (“TPP”) plaintiffs were allowed to misuse RICO to pursue what was essentially a garden variety inadequate warning case – that the drug Actos increased the risk of bladder cancer. What’s worse, the fraud on the FDA claim, if brought under state law, would be preempted by Buckman Co.

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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

JANUARY 4, 2024

The Complaint further alleges that data collected and submitted in support of full (as opposed to emergency use) FDA approval demonstrated the misleading nature of earlier statements. The FDA, however, did not and does not share that belief. FDA (8/23/21) press release (emphasis original). Health & Safety C.

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Drug & Device Law

FEBRUARY 20, 2023

But in prescription medical product liability litigation, products must receive FDA approval, clearance or other authorization (hereafter, collectively referred to as “approval” for short) before they can be marketed. to determine whether a proposed alternative drug would have received FDA approval.”

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Drug & Device Law

MAY 26, 2023

Ct. — , 2023 WL 3356528 (U.S. May 11, 2023) (“NPP”), evidences each of those old saws. In that case, the Fourth Circuit knocked out a Maryland law designed to prevent price gouging on drugs because of its extraterritorial reach. Politics makes strange bedfellows. So does the law. Weird cases also make weird law. 21–468, — S.

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Drug & Device Law

OCTOBER 10, 2023

Luminas Int’l LLC , like this—hey court, it’s not fair that I’m following the FDA’s rules and my competitors are not, so you should force them to do so to even the playing field. 12, 2023). To which the court appropriately said—you’ve come to the wrong place; FDA rules are the FDA’s to enforce. LEXIS 179285 (S.D.

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Drug & Device Law

MAY 10, 2023

The FDA, for all of the criticisms leveled against it, has a lot of expertise and energy when it comes to approving drugs and devices. It is simply unworkable, even nonsensical, to permit the states to impose varying, contradictory requirements on FDA-approved products. And then there is the Supremacy Clause.

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Drug & Device Law

NOVEMBER 2, 2023

A court within the Fifth Circuit has held that the FDCA impliedly preempts unfair-competition and consumer-protection claims asserted by a drug manufacturer against a compounding pharmacy. Despite generally rooting for drug manufacturers, we are okay with the decision, Zyla Life Scis., Pharmacy v. 2023 WL 6301651, at *4.

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