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Home » SBR USE ENCOURAGED TO LIGHTEN PRODUCT SAFETY PAPERWORK
SBR USE ENCOURAGED TO LIGHTEN PRODUCT SAFETY PAPERWORK
March 1, 2004
To help lighten the paperwork load associated with product safety information requests, the FDA is encouraging drugmakers to use summary bridging reports (SBRs) when regulatory authorities seek safety data spanning beyond a single periodic safety update report (PSUR).