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Sheraton Philadelphia University City

2017 年 10 月 23 日 7:30 上午 - 2017 年 10 月 26 日 5:00 下午

3549 Chestnut Street, Philadelphia, PA 19104

Regulatory Affairs: The IND, NDA, and Postmarketing

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Session 19: Regulatory Requirements for Prescription Drug Labeling

Session Chair(s)

Michael Hamrell, PhD, RAC

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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