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On October 3, 2012, Health Canada issued a press release announcing that it will develop a framework for the marketing approval of drugs to treat rare life-threatening, seriously debilitating or serious chronic rare diseases that are commonly referred to as "orphan drugs."
In March 2010, the United States Food and Drug Administration (FDA) announced its intention to rely more heavily on the "responsible corporate officer" (RCO) doctrine to prosecute individuals for violations of the federal Food, Drug and Cosmetic Act (FDCA
