FDA Nitrosamines—Health Risk Assessment and Mitigation Public Workshop -Final Report

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Sharing with our community members the final discussion report from FDA Nitrosamines as Impurities in Drugs—Health Risk Assessment and Mitigation Public Workshop help last March 29-30, 2021
Nitrosamine_Workshop_Report_Final-Jul-20-2021.pdf (313.9 KB)

It’s a great exercise to compare this document with the Q&A Industry meeting we recently post in the community

What steps is FDA taking or planing to take, to collaborate with other regulatory authorities to align on expectations for Step 2 confirmatory testing?

This and more questions related to Impact and Harmonization on this document recently published by FDA from a recent FDA-Industry meeting AAM/CHPA/PhRMA May 4th QA Written Responses_Joint Industry Group Meeting on Nitrosamines_final.pdf (133.3 KB)