Agency IQ

OCTOBER 27, 2023

Government shutdown: At present, the U.S. Prescription drug advertisements presented through media such as TV and radio must disclose the product’s major side effects and contraindications in what is sometimes called the major statement. Expect nearly every company to be closely reading this document when it’s eventually published.

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Agency IQ

DECEMBER 1, 2023

Government shutdown: At present, the FDA has appropriated funding through January 19. Both sections 503A and 503B provide that a compounded drug is not eligible for those exemptions if it is identified by FDA as presenting demonstrable difficulties for compounding. FDA finalized a ban on these devices in 2020, but the D.C.

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PLOS: DNA Science

OCTOBER 19, 2023

.” The ALS Association had previously stated “Our Position on NurOwn”: “After BrainStorm shared that its Phase 3 trial of NurOwn did not meet its primary or secondary endpoints, we have consistently requested access to the full data package so we could try to better understand its effect on people living with ALS.

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Agency IQ

OCTOBER 20, 2023

PFAS are used to repel water, oil, stains, and increase durability, and are found in a wide array of consumer and industrial products including non-stick cookware, fabric treatments, food packaging, cleaners, textiles, leather, cosmetics, paper and paints, fire-fighting foams (AFFF), and wire insulation. for uses under TSCA.

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The Pharma Data

MAY 13, 2021

I got hot flashes at the most embarrassing times (like when giving a presentation at work)… I would get out of breath just from running up a flight of stairs…. Even when they were presented with stressful situations…. So go ahead and choose your discounted package of HB5 right now…. Once you’ve selected your package….

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Agency IQ

JULY 28, 2023

to provide notice and an opportunity for owners or consignees of the drug to appear before the Agency and introduce testimony prior to the destruction of their drug. This rule also establishes standards for determining whether the major statement in these advertisements is presented in the manner required.

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Drug & Device Law

NOVEMBER 1, 2022

Starting with the to-be-published Mixson I , this IVC filter case presented rather complex choice of law issues because the plaintiff implantee was in the military when the surgery in question occurred, and the army sent him to Texas for treatment, even though he was a Florida resident. Testimony that the fall was a potential cause ?

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Drug & Device Law

DECEMBER 29, 2023

2023) (remote trial testimony cannot be compelled beyond Rule 45’s 100-mile limit on subpoenas) ( here ); Carson v. They excluded bogus expert testimony under Fed. Further, “adequacy” is an objective standard, that neither a plaintiff’s self-interested testimony nor equivocal health care provider testimony can touch.

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Drug & Device Law

MAY 12, 2022

When we heard a presentation last week from a Formula 1 executive, we paid it about as much attention as we pay most presentations in a room full of hundreds of lawyers. In our experience, plaintiffs prefer presenting on product or procedure risks without context of how those same risks apply to every other product.

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Drug & Device Law

MARCH 23, 2023

We return to Donalds not only because we realized that we have questioned each of the four experts plaintiff named, but because cases presenting permutations of this same fact pattern are still percolating through the courts. Southern Source Packaging, LLC , 568 F. Ethicon, Inc. , 22-1737, 2023 WL 2446703 (4th Cir. 10, 2023).

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Drug & Device Law

JUNE 6, 2022

Thus a confident learned intermediary’s testimony will defeat causation as a matter of law by stating that, notwithstanding a poor result, the treatment provided was standard of care, and even in hindsight they would not do anything different. Confident learned intermediaries stand by their medical decisions. Medrano , 28 S.W.3d

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