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Home » ADDENDUM TO ICH GUIDANCE CLARIFIES SAFETY REPORTING
ADDENDUM TO ICH GUIDANCE CLARIFIES SAFETY REPORTING
February 13, 2004
Drugmakers requested by a regulatory authority to file product information that spans several periodic safety update reports (PSURs) should file a summary bridging report (SBR), the FDA announced in a final International Conference on Harmonisation (ICH) guidance released last week.