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09. October 2017
This is an example pharmaceutical development report illustrating how ANDA applicants can move toward implementation of Quality by Design (QbD). The purpose of the example is to illustrate the types of pharmaceutical development studies ANDA applicants may use as they implement QbD in their generic product development and to promote discussion on how OGD would use this information in review.
18. February 2016
IPEC – FDA OGD Meeting – Inactive Ingredient Database Issues with ANDAs BACKGROUNDER DOCUMENT December 9, 2011
05. May 2015
By Zachary Brennan+Zachary Brennan, 05-May-2015 Inaccurate and incomplete information on excipients referenced in the US FDA Inactive Ingredient Database (IID), as well as other agency policies and guidance on the review of inactive ingredients in ANDAs (Abbreviated New Drug Applications) “continue to create confusion for the pharmaceutical industry,” according to a position paper from IPEC-Americas (International Pharmaceutical Excipients Council)....