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Sheraton Boston Hotel

Aug 14, 2017 7:30 AM - Aug 17, 2017 5:00 PM

39 Dalton Street, , Boston, MA 02119 , USA

Regulatory Affairs: The IND, NDA, and Postmarketing

Session 19: Regulatory Requirements for Prescription Drug Labeling

Session Chair(s)

Elliott  Berger, PhD, MS

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

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