小肯尼迪获参议院确认，出任美国卫生部长FDA人数“翻倍”历程：权、责、人的匹配FDA 新药审评和检查职能恐因大规模裁员遭重创FDA 高层持续动荡，返岗政策加剧人才流失FDA 急召部分被裁员工返岗局长待定，FDA 忙着提前退休、交周报

如注册工艺未规定对流浸膏过筛，实际进行了过筛处理，这种属于工艺一致性不符吗？如果不是CPP，而且有经工艺验证符合要求，是否不算工艺一致性

限制进入屏障系统（Restricted Access Barrier System, RABS）是一种广泛应用于无菌药品生产的关键技术，其通过刚性屏障、手套端口和单向气流（UDAF）提供局部A级环境，用于无菌灌装、分装等关键工艺，旨在通过物理屏障和工程控制减少人为

What is the impact of recent U.S. policy changes and FDA reforms on CDMO companies in China?

Does FDA conduct surprise inspections on all Chinese products (including sterile products, oral products, and active pharmaceutical ingredients)? What principles determine surprise inspections and the

如果一个样品在氯化钠蛋白胨缓冲液中溶解澄清（溶液a），再取溶液a到缓冲液则出现析出（溶液b），那是否可以直接取溶液a，然后冲洗滤膜？还是一

先承认这是标题党... 欧盟 GMP（2022）附件 1 明确了专门针对 WFI 储罐的排气过滤器进行完整性测试的要求：“如果 WFI 储罐配备疏水性抑菌排气过

Given current FDA policies, what impact will there be on IND submissions for Chinese enterprises' gene therapy products, and how can they prepare in advance?

What situations trigger FDA surprise inspections? Will Field Alert Report (FAR) trigger them? Could you provide some examples?

What is the FDA's goal for overseas regulation? What direction does it guide pharmaceutical companies towards? Is it merely compliance, or are there other orientations?

What AI tools can help enterprises ensure internal compliance, accelerate real-time monitoring of submission data, and expedite the review of submission materials?

What are the innovations in FDA's review?

中国药企目前已经感受到了哪些方面的变化：审评尺度，缺陷程度，还是检查力度？受到了哪些影响？有哪些应对措施？这些变化是否是可逆的？What changes have Chinese pharmaceutical companies already felt: review standards, deficiency severity, or inspection

What are the FDA's regulatory trends for Chinese clinical study data (used for innovative drug submissions to FDA)?

What impact do recent FDA personnel and policy changes in the cell and gene therapy field have on Chinese enterprises conducting clinical studies in the U.S. in this area?

Will changes in FDA personnel affect the review progress and standards of the Center for Devices and Radiological Health (CDRH)?

Which tracks in the Chinese pharmaceutical industry are mainly affected by recent FDA trends? Which type of pharmaceutical companies are most impacted?

请教一下各位老师，产品的处方组成中，注射用水是当做溶剂体现，按照药典4部注射用水进行检验，但是实际操作是注射用水灭菌后使用，灭菌后没有

中国药典正文项下残留溶剂多余注册标准，在工艺中并未使用到那些溶剂，按照注册标准执行还是药典标准