Agency IQ

OCTOBER 27, 2023

WUSF / AgencyIQ November 1 Initial deadline for NDSRIs Under a 2023 guidance document, the FDA has recommended that pharmaceutical companies assess Nitrosamine Drug-Related Substance Impurities for their products by November 1, 2023, with confirmatory testing due by August 1, 2025. to include devices.

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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.

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Drug & Device Law

JULY 24, 2023

We’ve discussed recently how a federal statute intended to allow suits against international terrorists has been misapplied as allowing suits against pharmaceutical companies. It is not clear that [defendants] will − or even can − avail themselves of a TPP-by-TPP causation defense using doctor-by-doctor testimony.

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Drug & Device Law

MARCH 16, 2023

In two of these cases, our client won summary judgment at the trial court level and an appellate court ended up creating a new cause of action to accommodate the plaintiff’s theory (and lack of helpful testimony from the prescribing physician). That gnaws at us, but the preemption analysis was simple and toothsome. 2023 WL 2386776, *3.

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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

FEBRUARY 25, 2022

The defendant first sought PLAC’s help on en banc rehearing, after suffering a loss on admission of expert testimony that we considered to be the worst decision of 2021. Notice how admissibility of expert testimony under Fed. Conversely, we think pharma/medical device companies need to have PLAC’s back. 19-2899 (8th Cir.

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