US Regulatory and Compliance Considerations
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Keyword(s)
Medical Communications; Medical Affairs; Medical Information; Pharmaceutical Advertising and Promotion; US Regulatory; FDA Guidances; eLearning; Online Learning

Credit Information
4 ACPE
0.4 IACET
0.4 IACET

Description
This module provides an overview of the regulations and guidance that govern the dissemination of information about drug products. This module focuses on governance in the United States. Other countries and regions have their own governing agencies with regulations that may or may not reflect those discussed here.
FEATURED TOPICS
- 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