E-PAGA wins

When the CARES Act signed into law in March 2020, it reformed and modernized the system under which a nonprescription drug can enter the U.S. market, both for industry and for the Food and Drug Administration (FDA). The FDA leveraged its history of collaboration with E-PAGA to design and develop a new online training course, Bringing a Nonprescription Drug to Market. The course educates stakeholders on the pathways to market a nonprescription drug, including the new provisions set forth by OTC monograph reform and the changes to how nonprescription drugs are regulated.

In 4 hours of self-paced independent study, course participants will cover:

• Key milestones in the regulation of nonprescription drugs.
• Nonprescription drug labeling requirements.
• Marketing a nonprescription drug under a new drug application.
• Marketing a nonprescription drug product under an OTC monograph.
• Compliance actions.

…and more.

Learn more about educational resources and training opportunities through the FDA’s Training and Continuing Education section.