Guidance for Industry: Providing Submissions in Electronic Format โ€“ 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 FAERS hinders FDA's ability to monitor product safety and public health. Furthermore, submission in PDF format prevents public access...through FAERS..."



03/13/2019, 10:55

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Open Access Tracking Project (OATP) ยป peter.suber's bookmarks


oa.pdf oa.xml oa.usa oa.usa.fda oa.pharma oa.medicine oa.obstacles oa.formats

Date tagged:

03/13/2019, 14:55

Date published:

07/01/2013, 10:55