Thursday, March 11, 2021

FDA Virtual Public Workshop on Nitrosamines – Drug Information Update

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FDA Center for Drug Evaluation and Research Division of Drug Information

FDA Announces Virtual Public Workshop on Nitrosamines as Impurities in Drugs; Health Risk Assessment and Mitigation Workshop

The Food and Drug Administration is announcing a virtual public workshop entitled: Nitrosamines as Impurities in Drugs; Health Risk Assessment and Mitigation Workshop. This workshop will be on March 29 and 30 and will include presentations and question and answer by expert panelists.

The workshop will include presentations on nitrosamines chemistry and toxicology and, on the finding of nitrosamines as impurities in drugs. The presentations will be followed by open discussion of questions prepared by FDA and presented to expert panelists for deliberations over two days. Topics to be addressed include nitrosamines as chemicals present in the environment, in food and, more recently, detected as impurities in drugs, nitrosamine pharmacokinetics, carcinogenesis, mutagenesis, (Q)SAR, and health risk assessment and mitigation. In addition, the panelists will be asked to identify data gaps and research needs to address uncertainties in nitrosamine safety assessment and how to prevent or minimize their presence in drugs.

Those interested in attending the virtual workshop should register early via Eventbrite. Registration is required for online attendance and will be available until 4pm on March 26, 2021.

Please see FDA's webpage for more information about the agency's efforts concerning nitrosamines in medications.

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