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4月3日,美国食品药品监督管理局(Food and Drug Administration,FDA)在 专门发布了针对 生产的未获NIOSH认证的呼吸器(口罩)获得EUA紧急授权(Emergency Use Authorization)的文件。该文件的发布给了许多正在抗击新冠病毒的国家带来了重要利好消息。这项紧急授权使得那些未获得NIOSH认证但符合特定标准的口罩可以在紧急情况下使用。 随着新冠病毒的蔓延,全球范围内对防护设备的需求愈发迫切。然而,由于供应链短缺和生产能力的限制,许多国家面临着呼吸器短缺的问题。此次FDA的紧急授权给了这些国家一个解决问题的新途径。 根据FDA发布的文件,获得EUA紧急授权的呼吸器须满足一系列要求。首先,产品必须是符合NIOSH标准的,但由于各种原因尚未获得认证。其次,制造商需要提供相关的测试数据和证据,证明产品的有效性和安全性。最后,申请公司需要提供一个详细的使用说明,以确保使用者正确佩戴和使用呼吸器。 虽然这项授权给了一定的灵活性,但FDA也强调了其紧急授权并非无限制。这些获得授权的呼吸器仅限于特定紧急情况下的使用,例如对于医疗机构和工作场所来说,确保供应链的稳定性以及人员的安全性非常重要。因此,FDA将会进行严格的监管和监督,确保授权的呼吸器符合要求并具备可靠的防护效果。 此次紧急授权的发布,不仅对那些正面临呼吸器短缺的国家来说是一项重要的支持,也对全球防控新冠疫情起到了积极的推动作用。笔者相信,在全球各国的共同努力下,这场抗击新冠病毒的战斗一定会取得最终的胜利。让我们携手共同应对挑战,保护健康,共创美好未来!

On April 3, the U.S. Food and Drug Administration (FDA) released a document on the official website that the respirator (respirator) manufactured in China without NIOSH certification obtained the emergency use authorization of the European Union.This announcement by the FDA has sparked both curiosity and concern among citizens and health experts alike. The document sheds light on the emergency use authorization granted by the European Union (EU) to Chinese-made respirators that lack the NIOSH (National Institute for Occupational Safety and Health) certification. The NIOSH certification is highly regarded as a symbol of trust and quality in respirator manufacturing. It ensures that the product meets rigorous standards and provides reliable protection against harmful airborne particles. Given this, the absence of NIOSH certification raises eyebrows and prompts questions about the EU's decision to grant emergency use authorization for these Chinese-made respirators. The European Medicines Agency (EMA) has been working tirelessly to assess and authorize the usage of medical products during the ongoing COVID-19 pandemic. With the shortage of respiratory protective equipment, their focus has been primarily on expediting the authorization process to ensure healthcare workers have access to adequate supplies. However, the decision to authorize the use of uncertified respirators seems to have caught many off guard. The FDA's release emphasizes that these respirators meet certain protective standards, despite lacking NIOSH certification. The question remains, how reliable are these standards compared to the NIOSH requirements? Are there alternative certifications or testing methods that the EU relies on in making such decisions? These are valid concerns that health experts and consumers would like to have clarified. In the effort to protect frontline workers, it is crucial to maintain transparency and confidence in the equipment being used. This is especially important when dealing with a global pandemic that has already taken countless lives and overwhelmed healthcare systems worldwide. The assurance of quality and effectiveness should never be compromised, as it directly impacts the safety of those risking their lives to save others. In response to the FDA's announcement, both the Chinese and EU authorities should provide detailed explanations regarding the emergency use authorization and the protective standards these respirators meet. By doing so, they can alleviate concerns and bolster confidence in the decision-making process. Furthermore, it is important for the relevant authorities to collaborate and share their findings with other international organizations involved in regulating and approving medical devices. This will facilitate a more comprehensive understanding of the certifications and standards being employed, fostering a collective effort in ensuring the safety and efficacy of respiratory protective equipment worldwide. In the midst of this global crisis, it is vital that governments, regulators, and manufacturers work together to maintain the highest standards of quality and safety. The health and well-being of healthcare professionals and the public depend on it.


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如何使用Twitter推广你的企业品牌(上篇)

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Twitter是一个简洁明了的信息通讯专用工具,容许您向定阅者(关注者)推送将近140字符的信息。您的Twitter能够包括偏向一切web內容(网络文章、网页页面、PDF文档等)或相片或视頻的连接。假如一张图片胜于万语千言,那麼在Twitter中加上一个照片会巨大地拓展你能共享的內容,足够超出Twitter的140字符的表述限定。大家关注(定阅)你的Twitter帐户,你也关注他人。这能够使你阅读文章、回应并轻轻松松地与你的跟随者共享或分享。 …


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