WASHINGTON, May 30 -- Food and Drug Administration has issued a notice called: Replacing Color Additives in Approved or Marketed Drug Products; Draft Guidance for Industry; Availability.
The notice was published in the Federal Register on May 30 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.
Summary: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Replacing Color Additives in Approved or Marketed Drug Products." This draft guidance provides recommendations for replacing color additives in approved or marketed drug products. If a color additive is replaced in a drug product, information to support the change should be ret...