Safety
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PMDA/PFSB Notification No. 0304004/2009: Guideline for the Quality, Safety, & Efficacy Assurance of Follow-on Biologics
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PSEHD/PED Notification No.0204-1 February 4, 2020 Guideline for the Quality, Safety, and Efficacy Assurance of Follow-on Biologics (PFSB/ELD Notification No. 0304007
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