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Generic drug manufacturers often change the way in which prescription drug ingredients are made in order to lower costs of making them, so this kind of contamination may be more widespread and undetected in generic drugs. [21] 2022–2023 United States P. aeruginosa outbreak in eye drops
The following are settlements reached with US authorities against pharmaceutical companies to resolve allegations of "off-label" promotion of drugs. Under the Federal Food, Drug, and Cosmetic Act, it is illegal for pharmaceutical companies to promote their products for uses not approved by the Food and Drug Administration (FDA), and corporations that market drugs for off-label indications may ...
The following is a list of the 20 largest settlements reached between the United States Department of Justice and pharmaceutical companies from 2001 to 2013, ordered by the size of the total settlement. The settlement amount includes both the civil (False Claims Act) settlement and criminal fine.
Two Indian chemical companies have been indicted for allegedly importing ingredients for the highly addictive opioid fentanyl into the United States and Mexico, the U.S. Department of Justice said ...
Gilead Sciences and the U.S. government have settled a billion-dollar patent dispute over Gilead's HIV prevention drugs Truvada and Descovy, according to a Wednesday filing in Delaware federal court.
The Health Insurance Portability and Accountability Act — otherwise known as HIPAA — has become a major topic of discussion amid the rollout of COVID-19 vaccines.
In 2012 the US Justice Department fined GlaxoSmithKline $3 billion for several violations, including withholding data on paroxetine, unlawfully promoting it for adolescents, and preparing a misleading article about study 329. New Scientist wrote in 2015: "You may never have heard of it, but Study 329 changed medicine." [28]
States and individuals have no Article III standing to block a federal individual mandate of $0 because there is no penalty: 7–2 TransUnion LLC v. Ramirez: 2021: Only plaintiffs concretely harmed by a defendant's statutory violation have Article III standing to seek damages against that private defendant in federal court: 5–4 FDA v.
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