1. Control of Nitrosamine Impurities in Human Drugs Guidance for Industry. Available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/control-nitrosamine-impurities-human-drugs. Accessed January 25, 2023.
2. Guidance on Nitrosamine Impurities in Medications. Available at: https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/information-health-product/drugs/nitrosamine-impurities/medications-guidance.html. Accessed January 25, 2023.
3. European Medicines Regulatory Network Approach for the Implementation of the CHMP Opinion Pursuant to Article 5 (3) of Regulation (EC) No 726 /2004 for Nitrosamine Impurities in Human Medicines. Available at: https://www.ema.europa.eu/en/documents/referral/european-medicines-regulatory-network-approach-implementation-chmp-opinion-pursuant-article-53/2004-nitrosamine-impurities-human-medicines_en.pdf. Accessed January 25, 2023.
4. Questions and answers for marketing authorisation holders /applicants on the CHMP Opinion for the Article 5 (3) of Regulation (EC) No 726 / 2004 Referral on Nitrosamine Impurities in Human Medicinal Products. Available at: https://www.ema.europa.eu/en/documents/referral/nitrosamines-emea-h-a53-1490-questions-answers-marketing-authorisation-holders/applicants-chmp-opinion-article-53-regulation-ec-no-726/2004-referral-nitrosamine-impurities-human-medicinal-products_en.pdf. Accessed January 25, 2023.
5. Pfizer Expands Voluntary Nationwide Recall to include All Lots of CHANTIX® (Varenicline) Tablets Due to N-Nitroso Varenicline Content. Available at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/pfizer-expands-voluntary-nationwide-recall-include-all-lots-chantixr-varenicline-tablets-due-n. Accessed January 25, 2023.