新闻中心

美国FDA要闻综述：FDA批准多聚糖止血系统（PerC

美国FDA要闻综述：FDA批准多聚糖止血系统（PerC

发布日期：2023-06-05 浏览次数： 131

2023年5月23日，美国FDA公布了以下新闻概览：

2023年5月22日，美国FDA和退伍军人健康管理局（VHA）宣布了一项新的合作，共同开发应急准备和响应工具及协议，旨在帮助提高医疗产品的制造能力与灵活性，并提高国内供应链在紧急情况、短缺和流行病期间的应变能力。一份新的谅解备忘录将有助于促进可信网络需求的开发，以支持分布式制造和数字库存的使用，最终使退伍军人和平民百姓能够更快地获得创新的医疗产品，为其护理提供支持。可通过FDA官网了解更多的相关信息，包括这些先进制造方法的描述。
2023年5月22日，美国FDA药品评价与研究中心（CDER）发布了两份指南快读（Guidance Snapshot），并附有两份指南摘要播客（Guidance Recap Podcast），以强调美国FDA致力于改善临床试验参与者的多样性，并提高对美国FDA于2020年发布的指南《增强临床试验人群的多样性 - 资格标准、入组实践和试验设计》（该指南针为增强临床试验人群多样性提供建议）的认识。其中一组指南快读+摘要播客供行业使用，另一组供患者社区使用。指南快读和指南摘要播客可让美国FDA以一种创新和更友好的方式在指南文件中提出建议，从而使更广泛的人群提高对美国FDA建议的认识。美国FDA致力于促进用于检验新疗法安全性和有效性的临床试验的参与者的多样性。
2023年5月19日，美国FDA批准了Artivion, Inc.的PerClot®多聚糖止血系统（PerClot系统），该系统预期用于外科手术过程中的止血（当其他传统止血方法无效或不切实际时）。PerClot系统由涂药器尖端和可吸收的多聚糖颗粒组成，多聚糖颗粒具有快速吸收水分的分子结构，形成凝胶粘合剂基质，从而提供防止出血的机械屏障。基于植物的多聚糖颗粒预期不用于神经外科手术或眼科手术。

英文原文

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:

· On Monday, the FDA and the Veterans Health Administration announced a new collaboration to jointly develop emergency preparedness and response tools and protocols intended to help increase medical product manufacturing capacity and flexibility, and improve resilience of domestic supply chains during emergencies, shortages, and pandemics. A new Memorandum of Understanding will help facilitate the development of requirements for trusted networks needed to enable the use of distributed manufacturing and digital stockpiles, which could ultimately enable veterans and civilians to more rapidly access innovative medical products to support their care. Learn more on FDA’s website, including descriptions of these advanced manufacturing approaches.

· On Monday, the FDA’s Center for Drug Evaluation and Research published two Guidance Snapshots accompanied by two Guidance Recap Podcasts to highlight the agency’s commitment to improve the diversity of participants in clinical trials, and to increase awareness of the agency’s 2020 guidance, Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria, Enrollment Practices, and Trial Designs, which presents recommendations sponsors can apply to diversify participation in clinical trials. One snapshot-podcast set is for industry, and the other set is for patient communities. Guidance Snapshots and Recap Podcasts are an opportunity for FDA to present the recommendations in guidance documents in an innovative and often more audience-friendly manner, thereby increasing awareness of the agency’s recommendations among a broader group of people. The FDA is committed to promoting the diversity of participants in clinical trials that test the safety and effectiveness of new treatments.

· On Friday, the FDA approved Artivion, Inc.’s PerClot Polysaccharide Hemostatic System (PerClot system) intended to help to control bleeding that can occur during surgical procedures when other conventional approaches for controlling bleeding are ineffective or impractical. The PerClot system is composed of an applicator tip and absorbable polysaccharide granules that have a molecular structure that rapidly absorbs water, forming a gelled adhesive matrix that provides a mechanical barrier against bleeding. The plant-based, polysaccharide granules are not intended for use in neurological or ophthalmic surgical procedures.

上一篇：夏季养生补气血的十种食物

下一篇：6月13日医讯早报 | 天津提升中医药传承创新能力

新闻中心

美国FDA要闻综述：FDA批准多聚糖止血系统（PerC

QQ咨询