Course Binder Materials

  • Full slides from the PowerPoint presentations
  • FDA Advertising & Procedural Guidances
    • Help-Seeking Guidance
    • DTC Broadcast Guidance & Q&A
    • FDAAA Pre-Dissemination Review Requirements
    • Product Name Guidance (All four versions from 1999, 2012, 2013 and 2017)
    • Presenting Risk Information Guidance
    • Social Media Guidances
      • Postmarketing Submissions Requirements
      • Responding to Unsolicited Requests for Off-Label Information
      • Presenting Risk Information in Space-Limited Contexts
      • Correcting Third-Party Misinformation
    • Distributing Off-Label Reprints
  • Relevant Sections of Code of Federal Regulations Form 2253
  • Updated 2019 PhRMA Principles on DTC Advertising
  • PhRMA Principles on Interactions with Healthcare Professionals
  • Preapproval Promotion Checklist
  • Key Resources for Continuing Education
  • Articles by Dale Cooke
    • Developing Compliant Search Engine Marketing Campaigns (Publication Date of September 2017)
    • Industry Standards for Linking Disease Awareness Websites to Product Promotion
    • Patient Testimonial Videos: FDA Actions on Risk Information Presentation
    • Presenting Risk Information on Websites
    • Where Things Stand on FDA Guidance on Social Media (Publication Date of September 2014)