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Guidance Documents/Guidance-Document/Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities

Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities

Detailed guidance document from FDA and regulatory agencies.

Document Details

Guidance Document

August 7, 2023

August 4, 2023

Center for Drug Evaluation and Research

6238372e-b9bf-421b-9c22-eda707398371

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