Memo to File…


Thoughts on those Memo-to-files or clarifying memos which are meant to help tell the story when missed in the initial report…

In a recently posted warning letter the responding firm identified corrective actions which included adding memos to provide additional or clarifying information relating to tests reported with no results or missing acceptance criteria. As these memos would be drafted after the fact, the FDA cautioned, in the warning letter, that an addendum that includes information (data) gathered after the fact i.e., not real data collected at the time of the initial study may raise data integrity concerns.