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Guidance Documents/Guidance-Document/Control of Nitrosamine Impurities in Human Drugs: Guidance for Industry

Control of Nitrosamine Impurities in Human Drugs: Guidance for Industry

Detailed guidance document from FDA and regulatory agencies.

Document Details

Guidance Document

September 5, 2024

September 4, 2024

Center for Drug Evaluation and Research

540c1e3e-a057-4a4f-9ede-0b1290a5cf04

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