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Quarterly Inactive Ingredient Database Change Log

2025202420232022202120202019Understanding the Change LogWelcome to the Quarterly IID Change Log. FDA publishes the IID on a quarterly basis. The Quarterly IID Change Log displays changes made since the previous quarterly IID publication.The Quarterly IID Change Log...

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Office of New Drugs Custom Medical Queries (OCMQs)

BackgroundOffice of New Drugs (OND) Custom Medical Queries (OCMQs), formerly known as FDA Medical Queries (FMQs), are standardized groupings of similar adverse event (AE) terms  intended to assist with the identification of potential safety issues during the review of...

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Standard Safety Tables and Figures (ST&Fs)

BackgroundThe Standard Safety Tables and Figures (ST&F) are designed to reduce clinical reviewers’ time in generating safety review content and to ensure consistency in the safety review of products across Divisions. Standards alignment has been addressed by taking...

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