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Sheraton Boston Hotel

14 ago 2017 7:30 a.m. - 17 ago 2017 5:00 p.m.

39 Dalton Street, , Boston, MA 02119 , USA

Regulatory Affairs: The IND, NDA, and Postmarketing

Session 26: Review of Prescription Drug/Biologics Advertising and Promotional Labeling

Session Chair(s)

Elliott  Berger, PhD, MS

Elliott Berger, PhD, MS

President

ETB Regualtory Consulting, United States

  • Definitions
  • Statutory basis for promotional regulations
  • Required elements for advertisements and promotional labeling
  • Reminder advertisements/labeling
  • Direct-to-Consumer (DTC) advertising
  • Social media
  • Disease awareness/help seeking
  • Launch of promotional pieces
  • Postmarketing submission of advertising
  • Preapproval promotional and dissemination of off-label information
  • FDA enforcement actions
  • Summary of principles for advertising and promotion

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