A process for compliance with revisions to FDA regulations

Revisions to Food and Drug Administration (FDA) regulations occur periodically and for a number of reasons. Whenever such a change occurs, it is necessary for pharmaceutical companies to evaluate that change for its products and to set in motion the appropriate actions to comply with the change in the regulations. When a change affects many products from the same pharmaceutical company, there is a risk that the implementation actions will be inconsistent across products unless some standardized process is adopted. This paper discusses the internal process used at Eli Lilly and Company to achieve standardization and to comply with revisions in FDA regulations. This process is described in detail with respect to the recent revision to the Pediatric Use subsection regulations. A map of the process and an example of its use with a specific product are also given. Finally, the steps in the process that lend themselves to generalization of the process to other changes in the regulations are discussed.