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Analysis Chemical Thank You Overview of the U.S. regulation of PFAS

Agency IQ

PFAS are used to repel water, oil, stains, and increase durability, and are found in a wide array of consumer and industrial products including non-stick cookware, fabric treatments, food packaging, cleaners, textiles, leather, cosmetics, paper and paints, fire-fighting foams (AFFF), and wire insulation.

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

Agency IQ

That law built upon several other previous laws, including the Public Health Threats and Emergencies Act of 2000, the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and the Project BioShield Act of 2004. But despite the law’s age, it is not yet fully operational.

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Origins of the Lab Mouse

Codon

That is—until the Austrian monk Gregor Mendel showed that traits are passed from parent to offspring in discrete, independently assorted packages. Nature (2002). In a testimony in front of the U.S. Rodents and primates share a common ancestor that split 80-90 million years ago in the Cretaceous. Credit: Hedges S.B.

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Article FDA Thank You Congress prepares to markup pandemic legislation, all but confirming FDA-related provisions won’t advance

Agency IQ

That law built upon several other previous laws, including the Public Health Threats and Emergencies Act of 2000, the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and the Project BioShield Act of 2004 ( see a Congressional Research Service report on its legislative history here ).

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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

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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 Medical Device Labeling Exception for “Commonly Known” Hazards

Drug & Device Law

That requirement comes with an exception: Provided, however , That such information may be omitted from the dispensing package if, but only if, the article is a device for which directions, hazards, warnings, and other information are commonly known to practitioners licensed by law to use the device. 801.109(c). Bard, Inc. , 3d at 1286.