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SAVE THE DATE: Drug Channels Leadership Forum, March 16-18, 2026

Drug Channels

Jason Dombi, Senior Vice President of Strategic Solutions, Cencora WATCH HIGHLIGHTS FROM DCLF 2025 Relive the #DCLF2025 energy and hear testimonials directly from participants. 2006-2025 HMP Omnimedia, LLC d/b/a Drug Channels Institute , an HMP Global Company. Cant see the video above? Click here. Have questions? All rights reserved.

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Analysis Life Sciences Thank You Everything the FDA is planning to do in Q3 2023

Agency IQ

A big nitrosamine deadline approaches : Unless you’ve been hiding under a rock for the last few years, you’ve probably heard about major issues that the pharmaceutical industry has been having with nitrosamine contamination. But despite the law’s age, it is not yet fully operational.

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50-State Survey of State Court Decisions Supporting Expert-Related Judicial Gatekeeping

Drug & Device Law

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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Unimpressed Learned Intermediaries Defeat Warning Causation

Drug & Device Law

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. . .

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The FDA and Feasible Alternative Designs

Drug & Device Law

2006), app. 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. 2d 839, 851 (N.Y. 2d 506 (N.Y.

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Confident Learned Intermediaries Defeat Warning Causation

Drug & Device Law

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 2d 141 (Pa.

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

Drug & Device Law

2006) – a precedential holding that the same Pennsylvania rule barring strict liability claims against prescription drugs also applied to prescription medical devices − should not be followed because the plaintiffs in Creazzo were supposedly “pro se.” Sanchez , 716 A.2d Janssen Pharmaceuticals, Inc. , Medtronic, Inc. , 3d 709 (Pa.