Guidance for Industry: Providing Submissions in Electronic Format โ€“ Postmarket Non-Expedited ICSRs Technical Questions and Answers

peter.suber's bookmarks 2019-03-13

Summary:

"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..."

Link:

https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM362174.pdf

Updated:

03/13/2019, 10:55

From feeds:

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

Tags:

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

Date tagged:

03/13/2019, 14:55

Date published:

07/01/2013, 10:55