FDA’s recent focus on potentially harmful color additives in food products has expanded to the pharmaceutical sector. In May 2025, FDA issued a draft guidance titled Replacing Color Additives in ...
The Food and Drug Administration has delayed the effective dates of its final order approving beetroot red and spirulina extract as color additives exempt from certification, following objections ...
FDA’s draft guidance outlines a flexible approach that, under certain circumstances, allows applicants and manufacturers to replace a color additive in an approved or marketed drug product with one ...
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