3.2.P采用CTD格式的简略新药申请.docVIP

ANDA in CTD format 采用CTD格式的简略新药申请 Application/submission 申请/申报 1.1 forms FDA form 1571 investigational new drug application Application to market a new drug, biologic or an antibiotic drug for human use 人用新药、生物或抗生素药物上市申请 FDA form 356(h) If doing a veterinary drug used form 356(v) FDA 表3397 用户费用说明书