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Bethesda North Marriott Hotel and Conference Center

Apr 08, 2019 1:45 PM - Apr 11, 2019 11:00 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Regulatory Affairs: The IND, NDA, and Post-Marketing

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Session 23: Requirements for Prescription Drug Labeling

Session Chair(s)

Elliott Berger, PhD, MS

Elliott Berger, PhD, MS

President

ETB Regualtory Consulting, United States

Definitions
Labeling Requirements of Immediate Containers and Cartons
Content and Format of Prescribing Information (PI)
Patient Labeling
Structured Product Labeling (SPL)

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