Also know as the Safety Update Report, the report must be received by the FDA within 120 days of drug approval submission (receipt by the FDA of the New Drug Application (NDA), comprising the CTD/Integrated Summary Report). Apr 14, 2020 Providing Postmarket Periodic Safety Reports in the ICH E2C(R2) Format (Periodic Benefit-Risk Evaluation Report) November 2016 Download the Final Guidance Document Read the Federal Register Notice. Worldwide, the most important aggregate report is the Periodic Safety Update Report (PSUR) and Development Safety Update Report (DSUR). This is a document that is submitted to drug regulatory agencies in Europe, the US and Japan (ICH countries), as well as other countries around the world.
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The information on this page is current as of April 1 2019.
Fda Pader Guidance
Periodic Adverse Drug Experience Report
For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).
Fda Periodic Safety Update Reports Psurs
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