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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.
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.
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
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.”
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).
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.
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.
Then, in 2014 the Court amended Rule 702 from mirroring its federal counterpart to expressly limiting the Daubert admissibility analysis to “novel scientific theory, principle, methodology, or procedure.” Evid. methodology underlying proffered expert testimony is scientifically valid and whether that. CSX Transportation, Inc. ,
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.
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). 2014) (Pennsylvania law), mucked things up and cases like Yates v. Wyeth , 619 F.3d
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.
Thus a confident learned intermediary’s testimony will defeat causation as a matter of law by stating that, notwithstanding a poor result, the treatment provided was standard of care, and even in hindsight they would not do anything different. Confident learned intermediaries stand by their medical decisions. Medrano , 28 S.W.3d
The prescriber’s] testimony, however, does not establish that he would have altered his prescribing conduct. Given this testimony, the plaintiffs could not “show that stronger manufacturer warnings would have altered the physician’s prescribing conduct.” Plaintiff] has not identified any testimony from [the prescriber] that. . .
Ferring Pharmaceuticals, Inc. The Federal Rules of Evidence do not permit an expert to render conclusions of law, because such testimony cannot properly assist the jury in understanding the evidence or determining a fact in issue. Rather, expert testimony couched as legal conclusion merely tells the jury which result to reach.
We return to a theme we’ve repeated twice before, in 2011 and in 2014 – that in addition to industry-specific groups, manufacturers of prescription medical products should definitely consider joining the Product Liability Advisory Council (“PLAC”). Boehringer Ingelheim Pharmaceutical, Inc. Janssen Pharmaceuticals, Inc.
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