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Draft laws, regulations and rules and policy plans on the administration and supervision of food (including food additives and health food, the same below) safety, drugs (including traditional Chinese medicines and ethno-medicines, the same below), medical devices and cosmetics; formulate normative documents, and facilitate the establishment and implementation of the food safety responsibility ...
The settlement amount includes both the civil (False Claims Act) settlement and criminal fine. Glaxo's $3 billion settlement included the largest civil False Claims Act settlement on record, [1] and Pfizer’s $2.3 billion ($3.5 billion in 2022) settlement including a record-breaking $1.3 billion criminal fine. [2]
The raw material for the recalled heparin batches was processed in China from pig's intestines by the American pharmaceutical firm Scientific Protein Laboratories. [1] [2] [3] The U.S. Food and Drug Administration was quoted as stating that at least 81 deaths were believed to be linked to a raw heparin ingredient imported from the People's Republic of China, and that they had also received 785 ...
Misclassification under the Medicaid Drug Rebate Program: False Claims Act: 2010 14 (tie) 13 Trileptal: Novartis [18] $465,000,000 $390 million ($465 million with co-defendant settlements) Off-label promotion/kickbacks False Claims Act/FDCA 2008 17 14 Actiq/Gabitril/Provigil: Cephalon [19] $425,000,000 $375 million civil ($425 million with ...
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The reversal will last until the president’s new plan to lower drug prices is in place or until the end of the year, whichever comes first. What Pfizer’s Drug Price Hike Reversal Really Means ...
The Food and Drug Administration has announced a recall for thousands of bottles of the antidepressant duloxetine, sold under brand names like Cymbalta, due to the presence of a chemical that can ...
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 ...