美国FDA 指导原则 根据《联邦食品、药物和化妆品法工业指南》第801(D)(1)(B)条进口FDA批准的某些人类处方药，包括生物制品和组合产品 英文原版.pdfVIP

Importation of Certain FDA- Approved Human Prescription Drugs, Including Biological Products, and Combination Products under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act Guidance for Industry U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) Office of Combination Products (OCP)