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Session 19: Regulatory Requirements for Prescription Drug Labeling
Session Chair(s)
Michael Hamrell, PhD, RAC
President
MORIAH Consultants, United States
- Definitions
- Requirements for Labels of Immediate Containers and Cartons
- Prescription Drug Labeling: Prescribing Information; Package Insert (PI)
- Prescription Drug Labeling Regulations
- Sections of the Labeling (Prescribing Information) under the Physician Labeling Rule
- Labeling for Systemic Antibacterial Drugs
- Structured Product Labeling
- Patient Labeling
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