美国FDA 指导原则 根据2017年仿制药使用费修正案评估使用费 英文原版.pdfVIP

Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 Guidance for Industry U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research May 2022 User Fees Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 Guidance for Industry