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.

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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. The following PDUFA dates were obtained from publicly available sources.

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The Pharma Data

MAY 13, 2021

Then these hormones can’t regulate your metabolism like they should…. Along with the amount of estrogen-regulating DIM that he added as well. It was like the floodgates burst wide open…. And the fat just came pouring off. When your thyroid isn’t producing enough of its two main hormones – T3 and T4…. So what’s the fix here?

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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

FEBRUARY 20, 2023

Without an FDA license to produce another design, [defendant] was legally prohibited from distributing either [alternative design advocated by plaintiffs] at the time [plaintiff] received her vaccinations. 7, 2022), which addressed the same question in the context of the admissibility of expert testimony. Wyeth Laboratories, Inc. ,

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Drug & Device Law

JUNE 13, 2022

The FDA’s regulations for medical device labeling generally require that such labeling include “any relevant hazards, contraindications, side effects, and precautions.” That testimony was contrary, not only to the common-law cases discussed in our prior posts , but also flatly contradicted §801.109(c). 801.109(c). 3d at 1286.

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Drug & Device Law

JUNE 1, 2022

Our favorite part of the plaintiff’s case was the reliance on unsworn affidavits and prior testimony by a Dr. Kory, who stated that he is “generally considered the foremost expert” on the proposed Covid treatment. One doctor wrote an ivermectin prescription based solely on statements from the patient’s wife.

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Drug & Device Law

MARCH 9, 2022

The issue in Robinson was the admissibility of testimony by the plaintiff’s regulatory expert. When we consider the damage a regulatory expert can do, misinterpreting both company documents and FDA regulations to make the company look like Murder, Inc., How does such testimony meet the relevance requirement of Fed. Evidence 402?

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