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GUIDANCE DOCUMENT

Identification of Medicinal Products — Implementation and Use March 2023

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2023-D-0266
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

This guidance is for sponsors, applicants, and registrants who are involved in the regulatory submission of medicinal product data. The guidance supports the development and implementation of the International Organization for Standardization (ISO) Identification of Medicinal Products (IDMP) standards for substances, terminologies, and other information for use throughout the global medicinal product development lifecycle. The purpose of these standards is to enable improved accuracy, completeness, and consistency in the international exchange of medicinal product information among stakeholders.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2023-D-0266.

 
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