IPEC-Americas and the Generic Pharmaceutical Association (GPhA) are continuing their advocacy of FDA incorporating a family approach in the toxicology assessment of excipients as they work with the agency on further improving the inactive ingredient database (IID) to support better drug development and more efficient FDA reviews.
In a session on the IID at the GPhA Fall Technical Conference in early November in Bethesda, Maryland, Ashland Global Regulatory Affairs Manager Priscilla Zawislak, who is the Chair-Elect for IPEC-Americas, reviewed the discussions that the trade associations have been having with FDA since 2011 on the excipients database and the progress to date [Editor’s Note: For more on IPEC-America’s engagement with FDA on the IID, see IPQ August 29, 2015, January 18, 2015, and December 3, 2013].
Colorcon Global Regulatory Affairs Director David Schoneker, who chairs the IPEC-Americas maker & distributor relations committee, followed Zawislak to the podium to discuss the importance of the family approach for excipients and the work done to date to get FDA’s buy in along with: ● IPEC-Americas’ evaluation of the changes to the IID made in August ● the association’s response to an FDA docket opened in July to solicit industry input on the IID, and ● next steps.
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