On the ANDA Refuse to File (RTF) checklist, Item 4 of CMC drug product section states “Does the application data include all of the 3.2.P Drug Product sections in the format of CTD module 3?”, is it permitted to remove those sections which are not applicable?

刊登日期:2021-11-17  |  點閱次數 : 429 次 

No, those CTD sections which are not applicable should be kept and marked with “not required” or “not applicable”. It is also acceptable to make notations at the chapter table of contents.



上一筆 With regards to Items 6 and 12 of CMC drug product section on the ANDA Refuse to
下一筆 If submitted application contains a drug product packaged in various sizes of pla