Agency IQ

JULY 28, 2023

On March 27, the FDA finalized a transition guidance document covering products that had been marketed under enforcement discretion policies during the PHE. First, by March 2021, manufacturers were expected to conclude a risk assessment of their approved or marketed products to assess the risk of nitrosamines.

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Agency IQ

OCTOBER 20, 2023

Data from the 2012, 2016, and 2020 CDR and 1998, 2002, and 2006 Inventory Update Reporting (IUR) Rule are included in the PFAS Analytic Tools. While there are a variety of reporting thresholds, sites manufacturing or importing 25,000 pounds or more of a chemical substance in a given year are required to report to CDR.

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Codon

JUNE 2, 2024

This discordance, or lack of “ predictive validity ” when translating results across organismal boundaries, is perhaps most harmful in the biomedical field; despite extensive testing in mouse models, only 10 percent of drugs that make it to clinical trials ever make it to market. Adapted from Yoshiki and Moriwaki (2006).

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Drug & Device Law

JANUARY 15, 2024

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.” Central Medical Health Services, Inc. , Medtronic, Inc. , 2d 521 (Pa. Ethicon, Inc. ,

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Compliance Government Production FDA Compliance 52

Drug & Device Law

FEBRUARY 20, 2023

In product liability litigation generally, plaintiffs have been allowed to invent all kinds of “alternative” designs as long as some “expert” opines that the design (even if never before marketed) is “feasible.” 2006), app. 2006), app. For physicians to prescribe such a safer drug, it must reach the market. 2d 506 (N.Y.

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FDA FDA Approval Testimonials Vaccine 59

Drug & Device Law

JUNE 6, 2022

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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Drug & Device Law

MAY 30, 2022

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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