美国FDA 指导原则 根据《联邦食品、药品和化妆品法》第503B条对人类药物复方外包设施进行登记 英文原版.pdfVIP

Registration of Human Drug Compounding Outsourcing Facilities Under Section 503B of the FDC Act Guidance for Industry U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Procedural November 2014 Contains Nonbinding Recommendations Registration of Human Drug Compounding Outsourcing Facilities Under Section 503B of the FDC A