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

Agency IQ

As part of the classification process, we are required to discuss the potential classification before an advisory committee and seek the committee’s recommendation on classification, which took place in October 2014.

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Analysis Life Sciences Thank You The 51 regulations that FDA is currently working on

Agency IQ

to provide notice and an opportunity for owners or consignees of the drug to appear before the Agency and introduce testimony prior to the destruction of their drug. To implement that authority, FDA published a final rule in the Federal Register on September 15, 2015 [80 FR 55237] which revised 21 CFR 1.94

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

Agency IQ

to provide notice and an opportunity for owners or consignees of the drug to appear before the Agency and introduce testimony prior to the destruction of their drug. 12/29/2023 FDORA, Section 3305 Medical Device Cybersecurity : GAO will publish a report “identifying challenges in cybersecurity for devices, including legacy devices.”

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No Expert Do-Overs

Drug & Device Law

2014), the MDL court let plaintiffs try again. Plaintiffs will not be heard to argue that they “could have shored up their cases by other means had they known their expert testimony would be found inadmissible.” 2d 449 (E.D. In re Zoloft Products Liability Litigation , 2015 WL 115486 (E.D. Weisgram v. Marley Co. , 440, 455-56 (2000).

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Dealing with the Pennsylvania Supreme Court’s Non-Decision on Standards Compliance Evidence

Drug & Device Law

Janssen Pharmaceuticals, Inc. , 2019), analogously held that the standard for admission of expert testimony was “procedural” and therefore Pennsylvania’s Frye rule applied, not Texas’ stricter expert admissibility standard. Coffing Hoist Division , 528 A.2d 2d 590 (Pa. Omega Flex, Inc. , 3d 328 (Pa. Sanchez , 716 A.2d 3d 709 (Pa.

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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. Takeda Pharmaceuticals Co. , Takeda Pharmaceutical Co. , 2014) (both complete with diagrams). 3d 1243 (9th Cir. 3d , 2023 WL 4191651 (C.D.