业界动态监管公开信息 · FDA
GDUFA III 对设施的变化
FDA Drugs · 2026-10-30 03:44
摘要
FDA 已根据《2017年仿制药用户付费修正案》（GDUFA II）承诺函完成了多项承诺，以提高设施检查优先级排序和日程安排的透明度。
English
GDUFA III Changes for Facilities
FDA has completed several commitments under the terms of the Generic Drug User Fee Amendments of 2017 (GDUFA II) commitment letter to provide greater transparency regarding prioritization and scheduling of facility inspections.