FDA’s draft guidance outlines a flexible approach that, under certain circumstances, allows applicants and manufacturers to replace a color additive in an approved or marketed drug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 ...
This is an archived article and the information in the article may be outdated. Please look at the time stamp on the story to see when it was last updated. U.S. regulators said Friday that they would ...
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 In May 2025, FDA issued a draft guidance titled Replacing Color Additives in ...