FDA issues safety update guidance addendum

Executive Summary

Summary bridging reports should be used to combine information presented in multiple periodic safety update reports, FDA says in 1addendum to the May 1997 guidance "E2C Clinical Safety Data Management: Periodic Safety Update Reports For Marketed Drugs." In addition, sponsors should use an addendum report to update a completed PSUR if the agency asks for safety data outside of the usual reporting cycle. The guidance was discussed during a March 2002 meeting (2"The Pink Sheet" March 18, 2002, p. 42)...