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Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

Agency IQ

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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Another RICOdiculous Decision

Drug & Device Law

We’ve discussed recently how a federal statute intended to allow suits against international terrorists has been misapplied as allowing suits against pharmaceutical companies. the relationship between [plaintiff] and its pharmacy benefit manager. . . According to Plaintiffs’ expert. . ., 2023 WL 4191651, at *8. 555, 565 (E.D.

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The FDA and Feasible Alternative Designs

Drug & Device Law

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. In at least the short term, a popular pain reliever would have to be removed from pharmacies. His testimony is thus irrelevant and inadmissible.

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