Marketing Pharmaceuticals: Labeling and Advertising Law Essentials

Drug Labeling and Advertising is a highly regulated activity, and it is critical for pharmaceutical companies to be familiar with all applicable federal laws and regulations. While FDA has primary authority in this area, other federal agencies, including the FTC, the PTO, the DEA, and the CBP, exercise limited authority.

This course will provide an explanation of Federal laws and regulations applicable to pharmaceutical labeling and advertising, as well as federal authority to investigate and take enforcement action against violative drug labeling and advertising. It will review FDA requirementts relevant to all drug labeling and advertising, and those that are specific to over-the-counter drugs and prescription drugs. Label content and format requirements will be explained, along with the exemptions from and modifications to the full labeling requirements. In addition to the FDA requirements, there will be a thorough review of other agency requirements, including FTC advertising standards, and PTO and CBP marking requirements, among others. FDA’s drug product listing requirements will also be explained.