根据FDA指南,年报需要包含的内容有:1. Form 3938 (1.1.11)
2. Cover letter (1.2)
3. Statement of Commitment
4. Tabular summary of amendments since last annual report
5. List of parties to whom LOA (Letter of Authorization) is issued till date
6. List of parties whose authorization letter is withdrawn (if applicable)
上述内容除了第1、2点在eCTD中有明确对应的section(见下图黄色高亮处),那其他内容应该放在哪个文件夹下呢?倒是有一个section1.13 Annual Report,但似乎没有对应的子目录可以放第3-6点的内容...