18. February 2016
IPEC – FDA OGD Meeting – Inactive Ingredient Database Issues with ANDAs BACKGROUNDER DOCUMENT December 9, 2011
07. September 2015
Discussions with FDA IID Working Group Representatives from IPEC-Americas recently met with FDA's Office of Generic Drugs (OGD) Inactive Ingredient Database (IID) Excipient Working Group on Thursday, July 30. The working group has been meeting regularly since December 2011 to address and improve FDA's IID database. One of the main purposes of the team is to help resolve current issues with the FDA IID, which have ultimately impacted abbreviated new drug applications (ANDAs). More
07. May 2015
By Lisa Tan - Associate VP Science and Regulatory Affairs at Generic Pharmaceutical Association As industry and the Agency enter into the third year of the generic drug user fee program, industry is still plagued with outstanding questions and concerns regarding the current and future state of the IID. I was invited by IPEC-Americas to present at the 2015 ExcipientFest held in San Juan, PR an industry prescriptive on the IID...bridging the past, current, and possible future state of the IID....