Agency IQ

DECEMBER 1, 2023

12/29/2023 FDORA, Section 3202 Orphan Drug Program : FDA will convene a public meeting (or several) to solicit input from stakeholders regarding rare disease patient burdens, treatment options, side effects of treatments, etc. Within 180 days, FDA will release a report on the proceedings of the public meeting and any recommendations.

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The Pharma Data

MAY 13, 2021

What I learned on the DVDs was the missing link when it comes to evaluation and eventual treatment of my clients planning for patients with muscular dysfunctions.”. ll see, and treatment strategies from some top notch names in our industry: Mike Robertson, Bill Hartman, Eric Beard, Rick Kaselj, Kevin Yates, and Dean Somerset.”.

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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.

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PLOS: DNA Science

OCTOBER 19, 2023

Also recently, FDA’s Cellular, Tissue, and Gene Therapies Advisory Committe turned down a stem cell treatment for amyotrophic lateral sclerosis, aka ALS, Lou Gehrig’s disease, or motor neuron disease. The only treatment for ALS is a drug, Riluzole , taken as a tablet or a film. The pace though varies quite a lot.

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The Pharma Data

MAY 13, 2021

So go ahead and choose your discounted package of HB5 right now…. And the answer is to simply click on one of the packages you see below right now…. Once you’ve selected your package…. Right now I want you to go ahead and select one of the three packages you see below…. And choose the most popular six bottle option….

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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. But despite the law’s age, it is not yet fully operational. The final rule will amend the administrative destruction provisions in 21 CFR 1.94

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Codon

JUNE 2, 2024

That is—until the Austrian monk Gregor Mendel showed that traits are passed from parent to offspring in discrete, independently assorted packages. Without mouse models, we may never have developed polio and meningitis vaccines, organ transplants, GLP-1 drugs, gene therapies , or any other number of transformative treatments.

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Agency IQ

JULY 13, 2023

Each of these re-authorizations, along with provisions in other, related legislative packages such as the 21 st Century Cures Act , sought to add to, tweak and/or amend the U.S. The House PAHPRA reauthorization package does include some interesting provisions. public health emergency preparedness and response infrastructure.

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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

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

MAY 12, 2022

We actually wrote previously about rulings in this case , including the rejection of the plaintiff’s argument that defense experts could not dispute the theory that polypropylene degrades in the human body because of the testimony of a corporate representative. About a week earlier, the court had issued rulings on a few defense motions.

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Drug & Device Law

MARCH 23, 2023

The typically gentle treatment from the MDL did not last and the plaintiff ended up with her sole case-specific causation expert excluded and her case tossed on summary judgment. (Not Southern Source Packaging, LLC , 568 F. at *5 (quoting Gallagher v. 2d 624, 631 (E.D.N.C.

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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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Drug & Device Law

MAY 30, 2022

The prescriber’s] testimony, however, does not establish that he would have altered his prescribing conduct. That oncologists prescribing lifesaving standard-of-care treatment in the face of “aggressive cancer” are not impressed by a risk of – permanent hair loss – is not surprising. at *3 (emphasis original). 2d 806, 817 (5th Cir.

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