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The Westin Boston Waterfront

Aug 15, 2016 7:30 AM - Aug 18, 2016 5:00 PM

425 Summer Street, Boston, MA 02210

Regulatory Affairs: The IND, NDA, and Postmarketing

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Session 19: Regulatory Requirements for Prescription Drug Labeling

Session Chair(s)

Drusilla Scott, PhD, RAC

Drusilla Scott, PhD, RAC

Vice President, Regulatory Affairs

Sobi, Inc., United States

Carol H. Danielson, DrPH, MS, RAC

Carol H. Danielson, DrPH, MS, RAC

President

Regulatory Advantage, LLC, 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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