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Seaport Hotel

Aug 12, 2019 7:45 AM - Aug 15, 2019 5:00 PM

One Seaport Lane, Boston, MA 02210

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

Learn about FDA regulations and expectations for the content, submission and review of INDs/NDAs, and the importance of regulatory strategy.

Back to Agenda

Session 24: Requirements for Prescription Drug Advertising and Promotional Labeling

Session Chair(s)

Drusilla Scott, PhD, RAC

Drusilla Scott, PhD, RAC

Vice President, Regulatory Affairs

Sobi, Inc., 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
  • Post-Marketing Submission of Advertising
  • Pre-Approval Promotion and Dissemination of Off-Label Information
  • FDA Enforcement Actions

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