FDA 人用药物中亚硝胺杂质控制指南 中英.pdfVIP

FDA Guidance for Industry -- Control of Nitrosamine Impurities in Human Drugs 202009 Control of Nitrosamine Impurities in Human Drugs 人药中亚硝胺杂质的控制 Guidance for Industry 行业指南 This guidance is for immediate implementation. 本指南立即实施 FDA is issuing this guidance for immediate implementation in accordance with 21 CFR 10.115(g)(2). Submit one set of either electronic or written comments on this guidance at any time. Submit electronic comments to . Submit written comments to