近日,美国众议院传来消息,以396比26的投票结果高票通过了此前争议已久的“21世纪治愈法案”(21st Century Cures Act)。该法案的最终版内容包括:改革FDA的新药评审程序,并在未来十年内继续扶持“癌症登月计划”、“精准医疗计划”等医学研究计划,鼓励美国医疗创新。 “21世纪治愈法案”主要内容包括: (1)未来10年内...
简称“ONC”)和医疗保险与医疗补助服务中心(Centers for Medicare & Medicaid Services,简称“CMS”)最近发布了有关实施《 21世纪治愈法案》(21st Century Cures Act)的互操作性和病患者资源可及性规定的规则。
如果在2024年9月30日以后拿到儿童罕见病药物资格,即使在2026年9月30日之前获得批准,也无法拿到优先审评券。 2016年,美国21世纪治愈法案(21st Century Cures Act)又增加了第三条可以获得优先审评券的途径,即颁发优先审评券给那些符合医疗对策的产品...
The article discusses the views of Margaret Hamburg, outgoing Food and Drug Administration Commissioner, on the concerns of releasing of 21st Century Cures Act that will speed up the approval pathway for medical technologies and drugs by allowing for more flexible clinical trial design.Dickson...
国际互联互通的需求是在不断增长,这跟咱们国内的情况是非常类似的。这些年美国在互联互通领域的政策跟实践还是不少的,比如大家可能听到过包括“有意义的使用(Meaningful Use)”,“21世纪治愈法案(21st Century Cures Act)”,还有更多的政策上的驱动。这里先介绍一下“有意义的使用(Meaningful Use)”. ...
Muspell Archive is a cloud-based, FHIR-native healthcare data archiving solution that ensures secure storage and retrieval of legacy EHR data. Compliant with both HIPAA and the 21st Century Cures Act regulations, it facilitates seamless Release of Information and supports patient-mediated data exchang...
As a prominent interoperability healthcare IT leader, eClinicalWorks is well-positioned to further advance the goals of the Trusted Exchange Framework and Common AgreementTM (TEFCATM) and the 21st Century Cures Act as an early EHR recipient of the QHIN designation. PRISMANet, the eClinicalWorks...
近日,美国FDA局长Scott Gottlieb博士和美国国立卫生研究院(NIH)院长Francis Collins博士在众议院能源和商业委员会(House Energy & Commerce Committee)就其机构如何努力执行“21世纪治愈法案”( 21st Century Cures Act)的规定作证,该法案由奥巴马总统在离任前一个月签署。听证会的重点在于庞大的新法律,其中包括FDA对药物...
Saul, for making this information more available and thus promoting the development of the medicine of the 21st century, Orthomolecular Medicine." (Abram Hoffer, M.D., Ph.D.) "I am always impressed how very well you do in films, your excellent choice of words to put your thoughts ...
再生医学高级疗法(RMAT)是由美国食品药品监督管理局(FDA)为根据21st Century Cures Act计划治疗严重或危及生命的病症的候选药物而指定的名称。RMAT超越了突破性治疗功能,它是一种允许加快批准药物。根据ARM的数据显示,2021年获得再生医学高级疗法(RMAT)审批的基因治疗药物有7项。