Introduction to Medical Combination Products

This course covers current FDA regulatory compliance with respect to developing and marketing Combination Products. A focus is placed on relevant aspects of FDA regulations as well as the practical aspects of getting the Combination Product to market. Several example products will be highlighted to provide practical, hands-on instruction.

The first part of the course provides general context for the overall topics surrounding combination products. Later, a more in-depth discussion on implementation within a complete combination product development environment is presented. FDA’s regulations, guidance documents, and on-line informational resources will be highlighted and used throughout the course.