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 In May 2025, FDA issued a draft guidance titled Replacing Color Additives in ...
FDA’s draft guidance outlines a flexible approach that, under certain circumstances, allows applicants and manufacturers to replace a color additive in an approved or marketed drug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 ...
FILE - Bottles containing a variety of colored liquids sit on a shelf in a lab at Sensient Technologies Corp., a color additive manufacturing company, in St. Louis ...
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