On December 9th, 2011 a team of five IPEC-Americas representatives met with about 20 representatives from the US FDA to discuss potential issues and concerns with the Inactive Ingredients Database (IID). The FDA has recently posted minutes and slides from the meeting, as well as an extensive backgrounder document (which was developed by the IPEC team and given to the FDA in advance of the meeting).
As a result of the meeting with the FDA in December 2011, the FDA formed an excipient working group to help work on and resolve issues as well as to improve the type of information listed in the database. Several IPEC meetings with the FDA are planned for 2012. IPEC-Americas members have been notified of these meetings and their participation is welcomed and encouraged!
During it's February meeting, IPEC-Americas Regulatory Affairs Committee discussed 1) formation of an IID Subcommittee to work with the IID Team in supporting and preparing information for routine FDA meetings and 2) developing a priority list of excipients that have had issues with recent IID list changes. At this time, ALL IPEC-Americas member companies are being asked to consider the following questions:
• Is your company interested in being a part of this IID Subcommittee?
• Are there excipients that your company wants to have included in the FDAdiscussions and if so, is there a representative from your company who would be willing to work with the Subcommittee to develop a proposal to share with the FDA?
IPEC-Americas is very interested in any comments you might have to the above questions. If you would like to respond to the questions or have additional comments, please send them to:
Katherine L. Ulman
IPEC Americas Vice-Chair for Science and Regulatory Policy
Non-members may attend IPEC-Americas committee meetings as a guest. Please consider coming to a meeting to find out the many activities our members participate in. If you want to attend, please contact Tammy Kramer, Office Manager at firstname.lastname@example.org