Master Files

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FDA issues draft guidance on NDIN Master Files

By Stephen Daniells

The Food and Drug Administration (FDA) has released draft guidance for industry titled “New Dietary Ingredient Notification Master Files for Dietary Supplements.”

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All eyes on Dietary Supplement Master Files

By Danielle Masterson

Fresh off a new Draft Guidance release, many are hopeful that Master Files would provide clarity on NDI filing requirements and provide protections for intellectual property. However, some point to issues with the NDI framework and say that must be solved...


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