FCC Laws and the Junk Fax Rules
This module outlines JFPA restrictions on unsolicited fax ads, opt-out requirements, and EBR exceptions. State-specific rules and penalties are also […]
Regulatory Affairs
Package Inserts and Boxed Warnings
Focuses on FDA labeling requirements, including package inserts, boxed warnings, and medication guides. Reviews real-world FDA warning letters and their
AdvaMed
This training provides a concise overview of the AdvaMed Code of Ethics, which governs ethical interactions between medical device/technology companies
Regulatory Foundations & Drug Lifecycle
This group introduces the structure of pharmaceutical regulation in the U.S., covering the lifecycle of a drug and the roles
Foreign Corrupt Practices Act (FCPA)
This module covers the FCPA’s anti-bribery provisions, focusing on interactions with foreign officials and healthcare professionals (HCPs). Participants will learn
Risk Evaluation and Mitigation Strategy (REMS)
Explains the FDA’s Risk Evaluation and Mitigation Strategy (REMS) program, including requirements for high-risk drugs, compliance, and post-market safety monitoring.
The CAN-SPAM Act
This training explains CAN-SPAM rules for commercial emails, including opt-out requirements, sender identification, and penalties. Suggested For: Compliance Officers Field
History of Pharmaceutical Regulations
Traces the evolution of U.S. pharmaceutical regulations, from the 1906 Pure Food and Drug Act to modern FDA frameworks. Suggested
The FDA’s Office of Prescription Drug Promotion (OPDP)
Learn about FDA regulations for prescription drug advertisements, including risk disclosure requirements, fair balance, and differences between broadcast and print
Anti-Kickback Statute (AKS)
This module details AKS prohibitions on remuneration to HCPs, safe harbors, and high-risk activities. Participants will review enforcement cases and