Guidance for Industry: Providing Submissions in Electronic Format – Postmarket Non-Expedited ICSRs Technical Questions and Answers
peter.suber's bookmarks 2019-03-13
"ICSRs submitted in PDF format cannot be downloaded into the FAERS database [FDA's Adverse Event Reporting System]. Lack of access...in FAERS hinders FDA's ability to monitor product safety and public health. Furthermore, submission in PDF format prevents public access...through FAERS..."