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FDA Announces New Requirement for Electronic Drug Labels

FDA press release: “In a continuing effort to use modern information technology to help inform the public and health care providers and to further improve patient safety, the Food and Drug Administration (FDA) today began requiring drug manufacturers to submit prescription drug label information to FDA in a new electronic format. This electronic format will allow healthcare providers and the general public to more easily access the product information found in the FDA-approved package inserts (“labels”) for all approved medicines in the United States…These new electronic product labels will be the key element and primary source of medication information for “DailyMed” — a new interagency online health information clearinghouse that will provide the most up-to-date medication information free to consumers, healthcare providers and healthcare information providers. This information can be accessed through the National Library of Medicine.”

  • See also NLM’s MedlinePlus website.
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