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●美国食品药品管理局(FDA)去年建立的一种新的管理通道模式,使得一些具有前景的癌症早期临床药物有望提前进入市场。迄今,部分这些突破性药物已经进入到癌症治疗领域,患者将可以快速得到最新的救命药物。在美国,每天有大约4 500人被诊断为癌症。去年3月,美国国会就美国食品药品管理局(FDA)一项新的药品研发通道进行了讨论。会上,一个称为“癌症研究之友”(FOCR)的辩护组织(由肿瘤学专家、医疗卫生投资人和现任/前任FDA官员组成)提出,一些被证明在早期临床试验中产生巨大或出乎意料之外治疗效果的实验性药物,难以
● A new regulatory channel mode established by the U.S. Food and Drug Administration (FDA) last year has enabled some promising early-stage cancers to enter the market ahead of schedule. To date, some of these breakthrough drugs have entered cancer treatment and patients will be able to get the latest life-saving drugs quickly. In the United States, about 4,500 people are diagnosed with cancer every day. In March last year, the U.S. Congress discussed a new channel for drug development by the U.S. Food and Drug Administration (FDA). At the meeting, a defense group called Cancer Friends of Cancer (FOCR) (composed of oncologists, healthcare investors and incumbent / former FDA officials) suggested that some have been shown to be huge in early clinical trials Or unexpected experimental treatment of experimental drugs, difficult