FDA Excipient Database Plagued By Inaccuracies, Causes Confusion

 
• By Joanne S. Eglovitch

The pharma industry says major problems continue with FDA’s Inactive Ingredient Database, including listing inaccurate potencies and using different names for the same excipient. A recent update has some firms in a ‘panic’ to reformulate products for pending ANDAs because of lowered potency limits or outright removal of some excipients from the database.

FDA’s Inactive Ingredient Database has problems so serious that currently it is "meaningless," according to generics and excipient industry groups.

The problems were pointed out in comments submitted to FDA and at industry meetings after the agency sought public comment...

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