
一项正在白宫审查中的待定监管可能扩大对肽类的准入,这些肽类是主要未受监管的物质,深受健康健身博主欢迎,且备受罗伯特·F·肯尼迪 Jr. 卫生与公众服务部长青睐。
A pending regulation under White House review could expand access to peptides, largely unregulated substances that are popular with wellness influencers and Health and Human Services Secretary Robert F. Kennedy Jr.
在7月,一支向食品药品管理局(FDA)提供外部咨询的专家小组——其中包括与肽类行业有关联的个人——勉强建议将几种肽类列入该机构允许在药房混合的产品清单,尽管FDA科学家对此表示担忧。
In July, a panel of outside advisers to the Food and Drug Administration — which included individuals with connections to the peptide industry — narrowly recommended adding several peptides to the agency’s list of products that can be compounded, or mixed at pharmacies, despite concerns from FDA scientists.
美国肽类医学学院计划于周三与预算管理办公室(Office of Management and Budget)举行会面,讨论待定的监管措施。
The American Academy of Peptide Medicine is slated to meet with the Office of Management and Budget on Wednesday to discuss the pending regulation.
美国药房混合药品联盟(Alliance for Pharmacy Compounding)首席执行官斯科特·布鲁纳(Scott Brunner)周五表示,该通知“可能意义重大,但我们尚不知政策具体内容、涉及哪些肽类以及FDA可能对其混合提出哪些条件”。
Alliance for Pharmacy Compounding CEO Scott Brunner said Friday that the notice could be “potentially significant, but we don’t yet know what the policy says, which peptides it covers, or what conditions FDA may attach to their compounding.”