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)