USP’s Sheehan and Liu talk at AAPS PharmSci 360 abou getting novel excipients past the monograph hurdle through early engagement with FDA.
|Articles|September 17, 2020
Nitrosamine Testing: The Regulatory Aspects
Author(s)SGS
Detection of N-Nitrosodimethylamine (NDMA) impurities has led to regulatory warnings and product recalls. Pharmaceutical manufacturers must adopt a proactive approach to risk assessment and mitigation in relation to genotoxic contaminants.
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