单词 | black box warning |
释义 | > as lemmasblack box warning 4. Originally U.S. A type of advisory notice printed (usually within a heavy black border) on the packaging of or insert accompanying certain prescription drugs, warning of potentially dangerous or fatal side effects. Chiefly attributive, esp. in black box warning.A black box warning is the strongest advisory issued by the American Food and Drug Administration (FDA) on medications.A similar type of warning is issued by the Australian Therapeutic Goods Administration (TGA). ΚΠ 1968 Amarillo (Texas) Globe-Times 29 Feb. 2/5 He said that the ‘black box warning’ now affixed to the drug's explanatory literature on advertising ‘is probably the strongest one that exists, yet it doesn't seem to work.’ 1979 H. Simons & J. A. Califano Media & Business 43 The FDA would come back and say, okay, put a black box in your package insert, and that would change the marketing within a month. 1998 S. Fried Bitter Pills iii. xx. 344 The FDA agreed to approve it as a nonsedating antihistamine without a black box. 2008 Weekend Austral. (Travel ed.) (Nexis) 23 Feb. (Review section) 26 The TGA itself..announced it was imposing a ‘black box’ warning on the drug. 2009 R. Mayes et al. Medicating Children vi. 158 In the end, the FDA decided not to issue a black box label because the number of adverse cases was small. < as lemmas |
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