综合

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

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

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 impact does the introduction of many young auditors by FDA have on inspections? Has the overall style also changed?

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

Under the new FDA review process, will the frequency and intensity of surprise inspections for Chinese companies be affected? As a Chinese enterprise, how should we respond?

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

Regarding FDA's recent ban on transporting U.S. citizens' cells to China for cell modification,does this equate to FDA rejecting IND submissions for Chinese cell products in the U.S.?

Will inspections of clinical sites also increase? Will FDA's acceptance of Chinese investigator-initiated trials (IIT) data be affected?

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?

Regarding the inspection results of VAI, under the circumstances where the rectification plan and rectification commitments have been submitted, is it necessary to submit subsequent rectification evid

Is there a difference in the intensity of FDA inspections in China compared to India?

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

In FDA's pre-approval inspections (PAIs), what is the proportion of unnoticed inspections?

For inspections in China, excluding individual inspector-specific factors, what are the main focus points? Is it impurity control or data integrity?

What types and conditions of enterprises might be subject to surprise inspections? What is the workflow for implementing inspections? Compared to previous inspections, what are the differences besides


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