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FDA Efforts Continue to Make its Inactive Ingredient Database More Functional

Jul 31st, 2016

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FDA’s Office of Pharmaceutical Quality (OPQ) is sharpening its vision of how to increase the reliability and user input in its Inactive Ingredient Database (IID) to make it more beneficial to both internal and external users.

The ongoing improvement efforts include eliminating the backlog of entries, refining the data collection and change processes, and standardizing and rationalizing the way units for different dosage forms are handled.

FDA Center for Drug Evaluation and Research (CDER) IID Working Group leader Susan Zuk discussed the challenges the Office of Pharmaceutical Quality (OPQ) has been facing in improving the IID and its progress in addressing them at the IPEC-Americas ExcipientFest Conference in late April. She provided a further update at the GPhA CMC Workshop held in May 2016 in Bethesda, MD.

A comparison with reports from Zuk and industry experts in the latter part of 2015 (see IPQ December 22, 2015) show how the effort is evolving in the context of the dialogue with pharmaceutical users and excipient suppliers – a dialogue in which IPEC-Americas and GPhA are actively involved.

[The story continues for subscribers on p. 2.  Nonsubscribers can get information on IPQ subscriptions and licensing or individual story purchasing by contacting Wayne Rhodes ([email protected]).]

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