Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act: Draft Guidance for Industry(根据《联邦食品、药品和化妆品法》第 801(d)(1)(B) 条进口某些 FDA 批准的人类处方药，包括生物制品：行业指南草案)