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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The Pharma Data

MAY 14, 2021

Their waists got smaller… They also saw an improvement in fat-regulating hormones. And serves as your body’s “master regulating switch.” It’s so powerful that in a 4 month trial… A group of patients lowered insulin levels without changing their diets [21]. They also lost belly fat….

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Packaging Production Research Doctors 52

The Pharma Data

MAY 13, 2021

There’s also a lot of truth to what he’s saying… Because high insulin levels definitely are one of the major reasons behind your weight loss resistance. Then these hormones can’t regulate your metabolism like they should…. In a major double-blind clinical trial published in the American College of Endocrinology….

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Production Packaging Doctors Research 52

Drug & Device Law

DECEMBER 21, 2023

2023), was the Fifth Circuit’s blatantly politicized attack on the FDA’s regulation of abortion-related drugs. That makes no sense either, because at the time of FDA approval, not to mention before FDA approval, there is, by definition, no “newly acquired information” beyond what the FDA considered in its approval decision.

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Drug & Device Law

JUNE 1, 2023

We think that they can, and for a state (like Pennsylvania and a number of others) that still follows the “ Frye ” standard looking to the “general acceptance” of expert testimony as the touchstone to admissibility, a Rule 702 state-law equivalent might look something like this: Rule 702. E.g. , Walsh v. BASF Corp. , 3d 446, 461 (Pa.

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Testimonials Trials Science Government 59

Drug & Device Law

DECEMBER 5, 2022

Ultimately, the thumb that Freeman put on the scale didn’t matter, because the defendant won at trial despite that handicap. The Superior Court here “credited testimony from doctors who never implanted mesh, or who did so outside the state of California.” at 27 (testimony that “large” amount of material had to be “recycl[ed]”).

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Testimonials Doctors Production Trials 64

Drug & Device Law

JANUARY 15, 2024

It is not evidence of the underlying attributes of the product that make it compliant with regulations or standards, which is presumably admissible subject to the ordinary Rules of Evidence. and [defendants’] response thereto, the trial court did not abuse its discretion by disallowing the evidence. Ethicon, Inc. , 3d 1245 (N.J.

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