NDINs
FDA Issues Draft Guidance on NDIN Master Files for Dietary Supplements
On April 3, the U.S. Food and Drug Administration (FDA) announced the availability of a draft guidance for industry titled “New Dietary Ingredient Notification Master Files for Dietary Supplements.” The draft guidance is the FDA’s response to the dietary supplement industry’s requests for specific guidance on recommendations about master files for new dietary ingredient notifications ...
NDI Update
Industry offers reaction to the FDA NDI draft guidance, NDIN experiences and suggestions for proceeding until a finalized version is put forth.Since the 1994 passing of the Dietary Supplement Health and Education Act (DSHEA), the industry has had limited guidance on the statute requiring the submission of new dietary ingredient notifications (NDINs) to the U.S. ...
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