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Session 19: 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
- Prescribing information; package insert (PI)
- Sections of the labeling (prescribing information) under the Physician Labeling Rule
- Labeling for systemic antibacterial drugs
- Structured product labeling
- Patient labeling