![]() ![]() Periodic benefit–risk evaluation report: a European Union regulatory perspective. Arlett P, Postigo R, Janssen H, Spooner A. Aggregate analysis of regulatory authority assessors' comments to improve the quality of periodic safety update reports. Jullian S, Jaskiewicz L, Pfannkuche HJ et al. Periodic Safety Update Reports Apuntil Septem(PSUR 1) The first postmarketing evaluation for pancreatitis was initiated by Amylin and summarized in its first Periodic Safety Update Report (PSUR 1) submitted on November 30, 2005, which covered a reporting period from April 1, 2005, until Septem( 5 mos). introduced new concepts linked to the evolution of the traditional Periodic Safety Update Report PSUR from an interval safety report to a cumulative benefit. is intended to be a common standard for periodic benefit – risk evaluation on marketed products among the ICH regions. ICH E2C (R2) Periodic Benefit Risk Evaluation Report (PBRER). Fda Periodic Safety Update Reports Psurs. ![]()
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