FDA's Recent Quality Concerns with Excipients
Excipients, the inactive ingredients in pharmaceutical products, are essential drug product components that facilitate drug delivery, promote solubility, improve taste and, in general, allow active pharmaceutical ingredients to be transformed into useable dosage forms. For over 30 years, FDA has published the Inactive Ingredient Database (IID), a publicly available list of the excipients used in FDA approved drug products, as a tool for drug development. Over the years, FDA has made small gradual improvements to the IID in response to requests from industry. In this presentation, FDA will provide its vision for the IID as an essential tool for drug development.