Evidence based recommendations for healthcare The Medicare & Medicaid Agency Tools to promote health literacy The FDA Dietary Supplement Ingredient Advisory List is intended to alert the public when the FDA identifies ingredients that do not appear to be lawfully included in products marketed as dietary supplements. The official magazine of the Food and Drug Administration. “The “Purple Book” is an easy-to-remember nickname for the “Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations.” Using a color for the nickname of the list draws upon FDA’s long-held practice of using “The Orange Book” to refer to “Approved Drug Products with Therapeutic Equivalence Evaluations,” the Agency’s reference listing of all drugs approved under the Federal Food, Drug and Cosmetic Act. Over the years, health care professionals and other stakeholders have come to use the term “Orange Book” in place of this longer, official title. FDA wanted a similarly user-friendly term for a reference listing biologics, biosimilars, and interchangeable products. During a meeting, a staff member said, “how about purple?” Ever since, we’ve called it the “Purple Book.” “Government Resources
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