Guidance for Industry : Providing Submissions in Electronic Format : Postmarket Non-Expedited ICSRs : Technical Questions and Answers
peter.suber's bookmarks 2013-07-28
Summary:
The US Food and Drug Administration has issued a guidance for industry asking for individual case safety reports (ICSRs) in XML rather than PDF. "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...."