FDA Releases Draft Guidance on Using the Inactive Ingredient Database

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The draft guidance provides industry with a guide for using the database to assist in the development of drug products.

On July 10, 2019, FDA published draft guidance for public comment on the use of the Inactive Ingredient Database (IID). The guidance document provides information on how to use the IID when choosing inactive ingredients in the development of new drug products. The guidance also supports the agency’s efforts in the promotion of generic drugs as part of its Drug Competition Action Plan.

The guidance also describes how the agency uses the IID to support the safety of inactive ingredients. It describes the structure of the IID, the process for adding ingredients to the IID, and how information is presented in the database, which gives users a better understanding of how to use the information.

The IDD lists information on inactive ingredients used in FDA-approved drug products. Once an inactive ingredient is used in an approved drug for a specific route of administration it is not considered novel; therefore, the ingredient may not require extensive review by the agency the next time it is used in a new product.


Source: FDA