Agency IQ

JULY 28, 2023

October 1, 2023 [link] Regulations Expected to be Published in Q3These are taken from the most recent version of the White House’s Unified Agenda. Specifically, this ANPRM seeks comments, research, information, data, and responses from certain categories of stakeholders that can inform the Agency’s modernization of FDA’s recall regulation.

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The Pharma Data

MAY 13, 2021

Then these hormones can’t regulate your metabolism like they should…. In a 2015 study published in the Journal of Traditional and Complementary Medicine…. 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. So what’s the fix here?

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Drug & Device Law

FEBRUARY 11, 2024

et al. , “A Longitudinal Cohort Study of Emergency Room Utilization Following Mifepristone Chemical & Surgical Abortions, 1999–2015,” 8 H. 19, 2021) (admitting and excluding Studnicki testimony); Whole Woman’s Health Alliance v. FDA litigation that is now before the Supreme Court. We were hardly alone. & Man’l Epid’y.

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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

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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Drug & Device Law

FEBRUARY 20, 2023

0295, 2015 WL 5022618, at *12 (N.J. 14, 2015) (claimed alternative could not be considered for plaintiffs who “had their surgeries prior to the commercial availability of” the claimed alternative because it “was not approved by the Food and Drug Administration until June 2007 and was not commercially available until late” that year).

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Drug & Device Law

MARCH 30, 2022

Several of the rulings in Enborg are common to numerous mesh decisions out there, but there is a favorable decision about Rule 30(b)(6) deposition testimony not being a judicial admission that we have not seen addressed before in any detail. Consequently, the court denied the plaintiffs’ motion to exclude the expert testimony.

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Drug & Device Law

MARCH 28, 2022

A lot of the discussion in Tsao was case specific because the purported expert opinions at issue were among the most ridiculous we’ve ever seen – directly contrary to the controlling FDA regulations applicable to the particular drug. Rather, expert testimony couched as legal conclusion merely tells the jury which result to reach.

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