draft guidance
FDA Issues Draft Guidance on NDIN Master Files for Dietary Supplements
On April 3, the U.S. Food and Drug Administration (FDA) announced the availability of a draft guidance for industry titled “New Dietary Ingredient Notification Master Files for Dietary Supplements.” The draft guidance is the FDA’s response to the dietary supplement industry’s requests for specific guidance on recommendations about master files for new dietary ingredient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 ...
Industry Questions FDA Policy Notice on NDIs
On May 20, FDA’s (U.S. Food and Drug Administration) Center for Food Safety and Applied Nutrition (CFSAN) published a notice in the Federal Register announcing the availability of a draft guidance, “Policy Regarding Certain New Dietary Ingredients and Dietary Supplements Subject to the Requirement for Pre-market Notification.” Under the new policy described in this draft ...
New Draft Guidance for Probiotic Labeling Could Yield Inaccurate Product Labels, CRN Says
The U.S. Food and Drug Administration (FDA) recently released a draft guidance entitled “Policy Regarding Quantitative Labeling of Dietary Supplements Containing Live Microbials” to advise firms that manufacture, market or distribute dietary supplements that contain live microbial ingredients of the conditions under which the FDA intends to exercise enforcement discretion to allow firms to declare ...
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