Update on FDA's Inactive Ingredient Database
Excipients are subject to Current Good Manufacturing Practice (CGMP) requirements. In the past year FDA has encountered multiple quality concerns with excipients that have led to drug product recalls and adverse events. This talk will highlight the regulatory landscape regarding the FD&C act and excipients, as well as presenting recent case examples of FDA regulatory actions taken at various levels in the supply chain when quality concerns with excipients were found.