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01-Reference_2009 Guidance for industry RE Identification, Assessment, and Control of…

Supporting & Related Material · FDA-2023-N-1585 · posted May 8, 2023

Key facts

Document ID FDA-2023-N-1585-0002
Title 01-Reference_2009 Guidance for industry RE Identification, Assessment, and Control of Nitrosamine Drug Substance-Related Impurities in Human Drug Products; Establishment of a Public Docket; Request for Comments
Document type Supporting & Related Material
Subtype Background Material
Agency FDA
Docket FDA-2023-N-1585
Posted May 8, 2023

At a glance

  • 10–99 Public comments on this docket

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