IPEC says confusion around FDA review of excipients could delay ANDA review cycles

By 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). 

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