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戻る Agenda
Session 18: Regulatory Requirements for Prescription Drug Labeling
Session Chair(s)
Elliott Berger, PhD, MS
President
ETB Regualtory Consulting, United States
- Definitions
- Requirements for Labels of Immediate Containers and Cartons
- Content and Format of Prescribing Information (PI)
- Patient Labeling
- Structured Product Labeling (SPL)