FDA Updates Inactive Ingredient Database (IID) - Access IPEC-Americas Analysis

News category: 
Thursday, July 20, 2017

IID Quarterly Update Spreadsheet Highlights Recent Changes

Long time IPEC-Americas volunteer, Katherine L. Ulman, President, KLU Consulting, has been involved with IPEC-Americas and FDA’s Office of Generic Drugs (OGD) Inactive Ingredient Database (IID) Excipient Working Group since December 2011. The goal of the working group has been to address and improve FDA’s IID database and help resolve current issues with the FDA IID listings/content, which have ultimately impacted abbreviated new drug applications (ANDAs). Kathy has been actively monitoring FDA’s IID quarterly updates and maintains a spreadsheet that highlights where changes in the IID have occurred since 2015.

IPEC-Americas members can access the spreadsheet in the Document Depot on the website once logged in.  

Suppliers have used information from the spreadsheet to monitor changes/updates for products they manufacture, including new uses by drug companies. 

Pharmaceutical companies are using this information to monitor how changes in the database might impact their new drug applications (both NDAs and ANDAs) either directly or through prepared bridging arguments. 

Go to: www.ipecamericas.org and LOG IN to your account

Under the “REFERENCE CENTER” tab, click “DOCUMENT DEPOT” then click on “RESOURCES”