疫情时事：FDA更新了新冠疫情期间为患者提供REMS药物的最新政策

阿拉丁翻译苏琳

Coronavirus (COVID-19) Update: FDA provides update on patient access to certain REMS drugs during COVID-19 public health emergency

疫情时事：FDA更新了新冠疫情期间为患者提供REMS药物的最新政策

Today, the U.S. Food and Drug Administration took significant action to help increase the availability of ventilators and accessories, as well as other respiratory devices, during the COVID-19 pandemic to support patients with respiratory failure or difficulty breathing.
3月22日，美国FDA采取了一系列加大呼吸机、配件及其他呼吸设备提供的措施，以期在新冠疫情爆发期间，帮助呼吸衰竭或呼吸困难的患者。

The guidance issued today outlines several key steps.
此次发布的指南主要包括以下几点。

First, the guidance describes the agency’s intention to exercise enforcement discretion for certain modifications to these FDA-cleared devices. Normally, any time a manufacturer or user makes a modification to a ventilator device, for instance, adding wireless and/or Bluetooth capability for remote monitoring, those modifications can often trigger an FDA premarket review, which can delay the time it takes to get these devices to the bedside. The guidance also helps manufacturers ramp up their manufacturing by adding production lines or alternative sites, for instance, using non-medical device manufacturers such as automobile manufacturers, to start manufacturing ventilator parts. In recognition of the current pandemic situation, and to ease regulatory burden on manufacturers, the FDA is being flexible in not enforcing the premarket review requirement for these modifications.
首先，该项指南表示，针对经FDA批准设备的某些改进，FDA将授予自由裁量权。通常情况下，每当生产商或用户对呼吸机设备进行改进时，如添加无线和/或蓝牙功能进行远程监控等，需要先进行FDA的上市前审查，这大大延长了此类设备投入病床使用所需的时间。此外，该项指南还允许生产商增加生产线或利用另外的场地（例如，利用汽车生产厂等非医疗设备生产场所）以加快生产呼吸机部件。考虑到目前的疫情情况，为简化对生厂商的监管，FDA现阶段将不再对此类改进进行上市前审查。

Second, as outlined in this guidance, hospitals and health care professionals may use ventilators intended for other environments. For example, the guidance notes hospitals that could repurpose ventilators normally used for transporting patients in an ambulance into the hospital setting for long-term use. The FDA also provides recommendations for other alternatives that should be considered such as devices for treating sleep apnea, continuous positive airway pressure (CPAP), devices.
其次，指南还表示，医院和医护人员可使用其他类型的呼吸机。例如，医院可以改进平时用于救护车的呼吸机（平时仅用于将病人运送到医院），以长期使用。FDA还提出了其他的可供考虑方案，如治疗睡眠呼吸暂停症的设备、持续气道正压设备和其他设备等。

Finally, the agency encourages manufacturers, whether foreign or domestic, to talk to FDA about pursuing an emergency use authorization (EUA), which would allow them to distribute their ventilators in the United States. This includes U.S.-based manufacturers that were previously engaged in making medical devices, but which have capabilities to increase supply of these devices.
最后，FDA鼓励国内外生厂商向其申请紧急使用授权，以便能尽快在美国使用其呼吸机，包括此前一直从事医疗设备生产，但有能力在此期间加大生产供应的美国生厂商。

Taken altogether, these actions as outlined in the guidance demonstrates the FDA’s flexibility during this pandemic to help manufacturers and encourage increased production of ventilators.
总而言之，指南中概述的行动表明，FDA致力于灵活调整政策，以在疫情期间为生产商提供支持，鼓励增加呼吸机生产。

We are updating in real time frequently asked questions from labs and test developers, providing information on alternative sources of reagents, extraction kits, swabs and more. The toll-free line, 1-888-INFO-FDA, is in place to help laboratories with any questions they may have about the EUA process or getting supplies.
FDA会实时积极应对来自实验室和测试研发人员的常见问题，提供有关试剂、提取试剂盒、拭子等的信息。如实验室对申请紧急使用授权流程或获取物资有任何疑问，欢迎拨打免费热线1-888-INFO-FDA。

The FDA has been working closely with PPE manufacturers to understand their supply capabilities during this pandemic. The agency is also aware of challenges throughout the supply chain that are presently impacting the availability of PPE products and is taking steps to mitigate shortages that health care facilities are already experiencing.
FDA一直在与个人防护用品生产商密切合作，了解其在疫情期间的供应能力。FDA知道整个供应链都面临着挑战，个人防护用品的供应也不例外，因此其正积极采取措施缓解医疗设施出现的短缺。

syhorchid

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阿拉丁翻译苏琳

syhorchid 发表于 2020-3-24 22:59
了解一下

感谢查阅！