（美国食品药品监督管理局）

2023年7月11日，美国FDA公布了以下新闻概览：

7月11日美国FDA兽医学中心（CVM）详细介绍了中心为了防止非法甲苯噻嗪进入美国所采取的做法。中心正在与其他FDA办公室以及美国卫生与公众服务部共同合作，形成部分全政府合力，来应对这个日益严重的问题。2月，兽医学中心与FDA监管事务办公室合作，采取措施限制甲苯噻嗪的活*药性**物成分和成品制剂药品非法进入美国。

7月10日美国FDA与印度尼西亚共和国海洋事务与渔业部鱼类检疫检验局签署了一份保密承诺书。这代表着印度尼西亚踏出了重要的第一步，准备加入相关计划，保证出口至美国的虾的安全性。

7月7日，美国FDA批准上市Better Therapeutics的BT-001 - 仅限处方的电子治疗仪，预期用于为18岁及以上的2型糖尿病患者提供认知行为治疗。BT-001提供认知行为治疗，帮助那些正在接受医护人员治疗的使用者更好地遵循有助于糖尿病管理的行为。BT-001应当作为标准疗法的辅助方法。

每月，美国FDA大讲堂系列讲座均会讨论一项关键公共卫生挑战，介绍FDA如何将科学与创新应用至监管活动。FDA现邀请您参加下一场讲座（时间：2023年7月13日美国东部时间12:00-13:00）：“质粒之谜：寻找沙门氏菌的解决方案”。美国国家毒理学研究中心微生物研究员Kristina Feye博士将探讨不同的下一代测序平台的长处和局限性、质粒对于公共卫生以及在“同一个健康”议题范围内的重要性、以及质粒影响微生物组的不同方式。

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:

Today, the FDA’s Center for Veterinary Medicine (CVM) detailed how it is working to stop illicit xylazine from entering the United States. The Center is working in partnership with other offices across the FDA and Department of Health and Human Services as part of a whole-of-government response to this critical and growing issue. In February, in coordination with FDA’s Office of Regulatory Affairs, CVM took action to restrict the unlawful entry of xylazine active pharmaceutical ingredients and finished dosage form drug products into the country.

On Monday, the FDA signed a Confidentiality Commitment (CC) with the Fish Quarantine and Inspection Agency (FQIA) of the Ministry of Marine Affairs and Fisheries of the Republic of Indonesia. The CC is an important first step towards preparing Indonesia to participate in a program designed to ensure the safety of shrimp exported to the United States.

On Friday, the FDA authorized marketing of Better Therapeutics’ BT-001, a prescription-only digital therapeutic device intended to provide cognitive behavioral therapy (CBT) to patients 18 years or older with type 2 diabetes. BT-001 provides CBT to help users who are under the care of a healthcare provider better adhere to behaviors that aid in the management of diabetes. BT-001 should be used adjunctively with standard of care.

Each month, the FDA Grand Rounds lecture series highlights a key public health challenge, and how the FDA is applying science and innovation to its regulatory activities. The agency invites you to attend the next presentation on July 13, 2023, from 12 to 1 p.m. EST, on the topic, “The Plasmid Puzzle: Finding Solutions in SalmonellaExternal Link Disclaimer.” Kristina Feye, Ph.D., a research microbiologist at the National Center for Toxicological Research, will discuss the strengths and limitations of different next-generation sequencing platforms, the importance of plasmids in public health and across the One Health spectrum, and the different ways plasmids can impact the microbiome.

来源：FDA

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