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美国副总统奎尔(Dan Quayle)于1991年11月13日批示:FDA对药物批准过程的重大改革将大大缩短新药审批过程。在这项改革下,患重病和有生命危险的病人将因及早获得重要新药而受益。对那些不必要的法规束缚必须解决。因此,美国的竞争能力将得到加强。 FDA目前按两种程序审批药物 1.加速批准的药物:包括治疗重病和有生命危险的疾病的药物或者目前尚无其它可用替代药物的药物。
US Vice President Dan Quayle commented on November 13, 1991: The significant FDA reform of the drug approval process will significantly reduce the approval process for new drugs. Under this reform, patients who are seriously ill and at risk will benefit from early access to important new drugs. It must be solved for those unnecessary laws and regulations. Therefore, the competitiveness of the United States will be strengthened. FDA currently approves drugs in two procedures 1. Accelerated drugs approved include those for the treatment of serious and life-threatening illnesses or those currently without other available alternative drugs.