Periodic Adverse Drug Experience Report (PADER)

  • PADERs are postmarketing periodic drug safety reports required in the USA by FDA regulations §§314.80(c)(2) and 600.80(c)(2)
  • PADERs have largely been superceded by the Public Benefit-Risk Evaluation Report (PBRER) defined in ICH E2C(R2), following FDA endorsement in November 2012 of the format designed for harmonised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. 
  • 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/PBRERs 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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