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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 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 ...
FDA Current Good Manufacturing Practices: 2006 Mylan [20] $465 million Misclassification under the Medicaid Drug Rebate Program: EpiPen (epinephrine) False Claims Act: 2006 Schering-Plough [21] $435 million Off-label promotion, kickbacks, Medicare fraud Temodar, Intron A, K-Dur, Claritin RediTabs: False Claims Act, FDCA 2004 [22] Pfizer $430 ...
One of the pharma giant's top-selling products is about to face some intense competition.
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 ...
A eye drops recall pulling two brands of artificial tears are the latest development in what the Centers for Disease Control and Prevention calls an outbreak of “extensively drug resistant ...
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 ...
Diversion, abuse, and a relatively high rate of overdose deaths in comparison to other drugs of its group. This drug continues to be available in most of the world including the US, but under strict controls. Terfenadine (Seldane, Triludan) 1997–1998 France, South Africa, Oman, others, US Prolonged QT interval; ventricular tachycardia [2] [3]