Draft Guidance for Industry: Quality Guidance: Applications for Drug Identification Numbers (DINAs) for Pharmaceuticals (French, HTML)

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HTML

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Publisher-reported update

2023-09-03

This document is intended to provide guidance with respect to the Quality (Chemistry and Manufacturing) portion of Applications for Drug Identification Numbers (DINAs) for chemical entities. The purpose of the guidance document is to outline the Quality technical requirements and to assist sponsors in preparing the DINAs to ensure an effective and efficient review process.

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