Federal Agencies
Introduces key federal agencies (FDA, DEA, OIG, FTC, CMS) and their roles in drug commercialization, enforcement, and compliance. Suggested For: […]
Promotional Review Committees
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
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
FDA’s Marketing and Labeling Laws
This training covers FDA regulations for drug/device promotion, including labeling requirements, advertising rules and social media compliance. Suggested For: Compliance
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
False Claims Act (FCA)
Provides an overview of the FCA, including false claim standards, whistleblower provisions, penalties, and its impact on the pharmaceutical industry.
Dissemination of Materials
This training provides an overview of FDA regulations (21 CFR Part 99) governing the dissemination of information about unapproved/new uses