• FDA Jurisdiction Over Prescription Drug Advertising and Promotional Labeling
• FDA Regulatory Standards for Advertising and Promotional Labeling
• Requirements for Advertising and Promotional Labeling
• Special Types of Advertising and Promotional Events
• Promotion versus Scientific Exchange and Solicited versus Unsolicited Information
• On-Label and Off-Label Considerations
• Direct-To-Consumer Promotion
• Compliance and other law enforcement agencies

• This course is designed for professionals involved in:

  • Medical affairs
  • Medical communications
  • Medical information
  • Medical writing
  • Field-based medical affairs support (i.e., Medical Science Liaison)
  • Medical call center environment
  • Regulatory affairs
  • Clinical research
  • Professional education, training, and development
  • Document management/eSubmissions

Upon completion of this module, learners should be able to:

• Identify the authority and jurisdiction under which the FDA regulates the dissemination of information, including advertising and promotional labeling, about prescription drugs
• Recognize the regulatory requirements for prescription drug advertisements and promotional labeling
• Define the issues concerning the dissemination of information about a prescription drug product prior to its approval
• Determine issues around special types of advertising and promotional events and how they relate to healthcare professionals
• Identify on-label and off-label issues concerning approved prescription drugs and the issues concerning the dissemination of off-label information
• Recognize what information is classified as "scientific exchange" versus "promotional"
• Define the issues concerning direct-to-consumer advertising of prescription drugs
• Determine the interests of FDA and other federal and state law enforcement agencies in monitoring the dissemination of information about prescription drugs