FDA Draft Guidance on New Dietary Ingredient Notification Master Files for Dietary Supplements
USA
Apr 08, 2024
The U.S. Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry titled “New Dietary Ingredient Notification Master Files for Dietary Supplements.” This draft guidance responds to the dietary supplement industry’s requests for specific guidance on recommendations about Master Files for New Dietary Ingredient notifications (NDINs).
An NDIN Master File or Master File is a file containing identity, manufacturing, and/or safety information relating to a new dietary ingredient (NDI) that the Master File owner submits to FDA for use in evaluating a potential future NDIN. The intent of the guidance, once finalized, will be to help industry comply more easily with the NDIN requirement by providing recommendations on the content, submission, and use of Master Files.
For further information (in English), click on the Link
Check the full text of the documents (in English), click on the Link
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