Development Safety Update Report (DSUR) | PharmaBharat Tools

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Development Safety Update Report (DSUR) | PharmaBharat Tools

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Changes Being Effected(CBE-0)Changes Being Effected in 30 Days(CBE-30)Comparability Protocol Controlled Distribution Direct Healthcare Professional Communication(DHPC)Development Safety Update Report(DSUR)Educational Materials Post-Approval Change Management Protocol(PACMP)Prior Approval Supplement(PAS)Periodic Benefit-Risk Evaluation Report(PBRER)Post-Marketing Postmarketing Commitment(PMC)Postmarketing Requirement(PMR)Pharmacovigilance System Master File(PSMF)Periodic Safety Update Report(PSUR)PSUR Single Assessment(PSUSA)Qualified Person for Pharmacovigilance(QPPV)Risk Evaluation and Mitigation Strategy(REMS)Renewal Risk Minimisation Risk Management Plan(RMP)Signal Management Supplemental NDA(sNDA)Sunset Clause Urgent Safety Restriction(USR)

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RA Post-ApprovalDevelopment Safety Update Report

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Direct Healthcare Professional Communication (DHPC)Educational Materials

Development Safety Update Report(DSUR)

Post-Approval

Definition

An annual report that provides a comprehensive, annual review of safety information for an investigational drug under development.

Regulatory source

ICH E2F