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Food and Drug Administration Benzene Drug Reformulating Guidance

Food and Drug Administration Benzene Drug Reformulating Guidance
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International Council For Harmonisation , Drug Administration , States Pharmacopeia , International Council , Residual Solvents , New Drug Applications , Abbreviated New Drug Applications , Changes Being Effected ,

. . . Try, Try Again; But Enough is Enough

Is what the court finally had to tell plaintiff in Roshkovan v. Bristol-Myers Squibb Co., 2023 U.S. Dist. LEXIS 166742 (C.D. Cal. Sep. 19, 2023) in… ....

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Some Welcome Clarity on Preemption | Reed Smith

Every once in a while in this space we summarize law review articles. In the course of doing so, we typically pat ourselves on the back by announcing that we read such articles so that. ....

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Lack of "Newly Acquired Information" Defeats Plaintiffs' Claims in Zofran MDL | Faegre Drinker Biddle & Reath LLP

Zofran (ondansetron) has often been used to combat nausea during pregnancy. It has never been approved by the FDA for that indication, but clinical experience has not supported an. ....

United Kingdom , Faegre Drinker Biddle Reath , Boehringer Ingelheim Pharms Inc , Faegre Drinker Biddle , First Circuit , Products Liability Litigation , Changes Being Effected , Ingelheim Pharms ,

Court Denies Motion to Dismiss Claims Targeting a Biologic

The decision we report on today, Frye v. Novartis Pharms. Corp., 2022 WL 4305656 (E.D. Ark. 2022), leaves us shaking our heads. The court denied the… ....

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