1. Trends in FDA drug approvals over last 2 decades: an observational study;Batta;J. Fam. Med. Prim. Care,2020
2. Guideline on the Limits of Genotoxic Impurities,2006
3. Reflection Paper on the Qualification of Non-genotoxic Impurities,2018
4. Assessment Report. Procedure under Article 5(3) of Regulation EC (No) 726/2004 Nitrosamine Impurities in Human Medicinal Products,2020
5. 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;EMA/409815/2020 Rev,2024