2023-06587: Identification of Medicinal Products-Implementation and Use; Guidance for Industry; Availability
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The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for industry entitled "Identification of Medicinal Products--Implementation and Use." This guidance explains FDA's position and progress on aligning the Agency's standards to Identification of Medicinal Products (IDMP) standards, which the Agency supports, to identify and describe marketed medicinal products with the exception of investigational medicinal products, with the goal of harmonizing the standards for the international exchange of medicinal product data. The guidance is intended to assist sponsors, applicants, and registrants who are involved in the regulatory submission of medicinal product data.
The agency’s own summary, as published.
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