The Pharma Data

MAY 13, 2021

scientific trials and regulations, modern medicine by. pharmaceutical model, I truly believed in it, despite. Just read and watch the testimonials for. would even say that thanks to a system of proper. and large successfully balances the risks of drugs. against undoubted benefits they offer. since I. What they say.

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Drug & Device Law

FEBRUARY 11, 2024

Another of our posts quoted similar concerns raised by our clients in the pharmaceutical industry as the matter was being successfully appealed to the United States Supreme Court: The Fifth Circuit’s ruling threatens to stifle pharmaceutical innovation by disrupting industry’s reasonable investment-backed expectations.

FDA 59

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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. We] “borrow” the OSHA regulation for use as evidence of the standard of care owed to plaintiff. Janssen Pharmaceuticals, Inc. ,

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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. 2023) (HHS cannot force pharmaceutical manufacturers to sell unlimited amounts of prescription drugs at a discount) ( here ). They excluded bogus expert testimony under Fed. Bonta , 85 F.4th 4th 1263 (9th Cir.

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Drug & Device Law

DECEMBER 21, 2023

2023), was the Fifth Circuit’s blatantly politicized attack on the FDA’s regulation of abortion-related drugs. Takeda Pharmaceutical Co. , Luitpold Pharmaceuticals, Inc. Geri-Care Pharmaceuticals Corp. , FDA , 78 F.4th 4th 210 (5th Cir. Avoiding barnyard expletives – we shoveled Shikada here. 3d , 2023 WL 4191651 (C.D.

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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

The court in Wolfe refused to impose a negligence duty on the defendant pharmaceutical company to develop and obtain FDA approval of the plaintiff’s non-FDA-approved alternative. 7, 2022), which addressed the same question in the context of the admissibility of expert testimony. His testimony is thus irrelevant and inadmissible.

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Drug & Device Law

MARCH 28, 2022

Ferring Pharmaceuticals, Inc. 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. So we ran a search. High on the list was Tsao v. 2018 WL 3649714 (S.D.

Testimonials 59

Testimonials FDA Regulations Production 59

Drug & Device Law

JANUARY 24, 2022

In re Generic Pharmaceuticals Pricing Antitrust Litigation , MDL No. Valsartan Testimony ¶1; accord Blackbaud ¶2; Davol ¶2. Blackbaud ¶37; Generic Pharmaceuticals Pricing ¶2; Davol ¶1; Zantac at p.1. Valsartan Testimony ¶3. Generic Pharmaceuticals Pricing , ¶1; accord Blackbaud ¶12. “No March 10, 2021).

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