美国FDA的快速通道(Fast Track)是为了促进治疗严重疾病和解决未满足医疗需求的药物的审评而设立的一种特殊认定。快速通道为药物研发提供了相当大的灵活性,允许FDA根据更多的疗效指标来审批药物。快速通道计划不仅向患者、医生和保险公司传递积极信号,也向投资者发出积极信号。研究表明,获得快速通道称号的适应症在提供QALYs...
a life sciences and medical technology company and subsidiary of The iQ Group Global, announced it has filed an application with the U.S Food and Drug Administration (FDA) for Breakthrough Devices Designation for its Saliva Glucose Biosensor. ...
FDA授予伏美替尼快速通道(Fast Track Designation ) 炒股第一步,先开个股票账户 援引美国药食监局(FDA)与Arrivent消息,7月初第一位晚期或非小细胞肺癌患者已经进入1B期实验。并且,FDA已授予伏美替尼快速通道资格。 这里有两个可以关注的点: 一是有了FDA的快速通道后,能够加快伏美替尼的开发与审查,使得Arrivent...
2020年7月17日,索元生物宣布美国食品药品监督管理局(FDA)授予其全球首创新药DB102(Enzastaurin)用于一线治疗脑胶质母细胞瘤(GBM)的快速审评通道(Fast Track)资格认定。能够进入快速审评通道的条件是:目前无有效药物,新药能填补治疗空白,或者新药在有效性或安全性上有明显优势。通过加快药物审评的过程而使这些药物更早...
The FDA has granted fast track designation to MYTX-011 for use as a potential therapeutic option in patients with non–small cell lung cancer and cMET overexpression. The FDA has granted fast track designation to MYTX-011 for use as a potential...
8月3日,Moderna宣布,FDA授予mRNA疫苗mRNA-1345快速通道(Fast Track)资格,单剂用于预防60岁以上成人呼吸道合胞病毒(RSV)感染。 呼吸道合胞病毒是一种常见的呼吸道病毒,会引起感冒症状。大多数感染者可在一到两周内康复,但少数人,尤其是婴儿和老年人,病情可能会很严重。RSV是美国一岁以下儿童细支气管炎和肺炎最常...
“This Fast Track designation is an encouraging step in our ongoing research and commitment to advancing care of those with systemic sclerosis with interstitial lung disease,” said Christopher Corsico, M.D., Chief Medical Officer, Boehringer Ingelheim. “It is critical that we address the signific...
The FDA fast-tracks the New Drug Application (NDA) process if a therapy can potentially address an unmet medical need for a life-threatening disease. Designation as a fast-track product is designed to expedite regulatory review of the Bronchitol NDA. The FDA and European Medicines Agency have ...
FDA offers fast-track approval for lower-cost AIDS combinations
/PRNewswire/ -- Aspen Neuroscience today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for ANPD001 for the...