Periodic Adverse Drug Experience Report (PADER)

  • PADERs are postmarket periodic drug safety reports required in the USA by FDA regulations ยงยง314.80(c)(2) and 600.80(c)(2)
  • PADERs have largely been superceded by the new Public Benefit-Risk Evaluation Report (PBRER) defined in ICH E2C(R2), following FDA endorsement in November 2012 of the format designed for harmonised use across all ICH regions. The PBRER also forms the basis of the current version of the European Periodic Safety Update Report (PSUR).
  • PADERs/PBRERs are required to be submitted quarterly for the first 3 years after drug approval in the USA, and annually thereafter.
  • Trilogy’s experience with PSURs extends across a wide range of indications.
  • As a provider also of pre-approval safety documentation, CTDs and other drug approval documentation, Trilogy can also provide the 120 Day Safety Update required by the FDA immediately following CTD submission.
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