PDUFA和BsUFA季度招聘更新
正文 · 中文译文
PDUFA与BsUFA季度招聘更新 《处方药用户付费法案》（PDUFA VII）与《生物类似药用户付费法案》（BsUFA III） 《处方药用户付费法案》修正案 作为《处方药用户付费法案》（PDUFA VII）和《生物类似药用户付费法案》（BsUFA III）再授权的一部分，美国食品药品监督管理局（FDA）承诺按季度报告2023-2027财年（FY）招聘目标进展。下文将按每个财年（2023-2027）添加表格并按季度更新。 有关药物评价与研究中心（CDER）和生物制品评价与研究中心（CBER）净招聘数据的更多信息（除PDUFA VII和BsUFA III项下报告的数据外），参见CDER与CBER净招聘数据。 FY26招聘目标 下表列示了PDUFA VII在2026财年的未完成招聘目标，以及截至2026年9月30日FDA对这些招聘目标的完成百分比。 PDUFA VII 2026财年招聘目标 | 第一季度招聘人数*（2025/12/31） | 第二季度招聘人数*（2026/3/31） | 第三季度招聘人数*（2026/6/30） | 第四季度招聘人数*（2026/9/30） | 总计 | 完成百分比 生物制品评价与研究中心（CBER） | 1 | 5 | 0 | 0 | 2 | 2 | 13% 药物评价与研究中心（CDER） | 0 | 0 | 0 | 0 | 0 | 0 | 0% FDA其他部门 | 0 | 0 | 0 | 0 | 0 | 0% | 0% 总计全职等效人员（FTEs） | 1 | 5 | 0 | 0 | 2 | 2% | 13% *招聘是指截至指定日期已确认入职所注明中心的全职岗位的人员。虽然部分招聘人员来自中心/食品药品监督管理局（FDA）外部，但在某些情况下，招聘人员也可能是当前中心/FDA的员工在机构内部转岗。正如CDER与CBER净招聘数据页面所反映的，CDER尽可能从外部为新岗位招聘人员。 FY25剩余招聘 下表代表PDUFA VII和BsUFA III在2025财年的未完成招聘目标，以及截至2026年9月30日FDA这些招聘目标的完成百分比。 PDUFA VIIFY 2025招聘目标总招聘人数（截至2026年9月30日）完成百分比 生物制品评价与研究中心（CBER）291552% 药物评价与研究中心（CDER）151493% BsUFA IIIFY 2025招聘目标总招聘人数（截至2026年9月30日）完成百分比 药物评价与研究中心（CDER）100% FY25招聘目标 下表代表PDUFA VII和BsUFA III在2025财年的未完成招聘目标，以及截至2025年9月30日FDA这些招聘目标的完成百分比。 PDUFA VIIFY 2025招聘目标第一季度 招聘人数* （2024年12月30日）第二季度 招聘人数* （2025年3月31日）第三季度 招聘人数* （2025年6月30日）第四季度 招聘人数* （2025年9月30日）总计完成百分比 生物制品评价与研究中心（CBER）297100828% 药物评价与研究中心（CDER）157200960% 其他FDA0000000% 全职等效人员（FTE）总计44143001739% BsUFA IIIFY 2025招聘目标第一季度 招聘人数* （2024年12月30日）第二季度 招聘人数* （2025年3月31日）第三季度 招聘人数* （2025年6月30日）第四季度 Hires* (9/30/2025)TotalPercentage complete Center for Drug Evaluation and Research (CDER)1000000% TOTAL Full Time Equivalents (FTEs)1000000% *招聘是指已在指定日期确认入职所述中心全职岗位的人员。虽然部分招聘人员来自中心/FDA外部，但在某些情况下，招聘也可能是在机构内部转岗的现任中心/FDA员工。正如CDER与CBER净招聘数据页面所示，CDER尽可能从外部招聘新岗位人员。 Remaining Hires from FY24 The tables below represent the outstanding hiring goals from FY 2024 for PDUFA VII and BsUFA III and FDA’s completion percentage of those hiring goals as of September 30, 2026. PDUFA VIIFY 2024 Hiring GoalTotal Hires (as of 9/30/2026)Percentage complete Center for Biologics Evaluation and Research (CBER)483879% Center for Drug Evaluation and Research (CDER)312994% BsUFA IIIFY 2024 Hiring GoalTotal Hires (as of 9/30/2026)Percentage complete Center for Drug Evaluation and Research (CDER)100% FY24 Hiring Goals The tables below represent the outstanding hiring goals from FY 2024 for PDUFA VII and BsUFA III and FDA’s completion percentage of those hiring goals as of September 30, 2024. PDUFA VIIFY 2024 Hiring GoalsQ1 Hires* (12/30/2023)Q2 Hires* (3/31/2024)Q3 Hires* (6/30/2024)Q4 Hires* (9/30/2024)TotalPercentage complete Center for Biologics Evaluation and Research (CBER)48615573369% Center for Drug Evaluation and Research (CDER)3137762374% Other FDA0000000% 总全职等效人员（FTEs）7992212135671% BsUFA III 2024财年招聘目标 第一季度 招聘人数* （2023年12月30日）第二季度 招聘人数* （2024年3月31日）第三季度 招聘人数* （2024年6月30日）第四季度 招聘人数* （2024年9月30日）总计 完成百分比 药物评价与研究中心（CDER）1000000% 总全职等效人员（FTEs）1000000% *招聘人数定义为在指定日期前已被确认到岗、在所述中心担任全职职位的人员。虽然部分招聘人员是从中心/FDA外部招募的，但在某些情况下，招聘人员也可以是当前在中心/FDA内部调动职位的员工。正如CDER与CBER净招聘数据页面所反映的，CDER尽可能从外部为新职位进行招聘。 2023财年剩余招聘 下表代表PDUFA VII和BsUFA III在2023财年的未完成招聘目标，以及截至2026年9月30日FDA对这些招聘目标的完成百分比。 PDUFA VII 2023财年招聘目标 总招聘人数 （截至2026年9月30日）完成百分比 生物制品评价与研究中心（CBER）132132100% 药物评价与研究中心（CDER）777597% BsUFA III 2023财年招聘目标 总招聘人数 （截至2026年9月30日）完成百分比 药物评价与研究中心（CDER）141393% 2023财年招聘目标 下表代表PDUFA VII和BsUFA III在2023财年的未完成招聘目标，以及截至2023年9月30日FDA对这些招聘目标的完成百分比。 PDUFA VII 2023财年招聘目标 第一季度 招聘人数* （2022年12月31日） 第二季度 招聘人数* （2023年3月31日） 第三季度 招聘人数* （2023年6月30日） 第四季度 招聘人数* （2023年9月30日） 完成百分比总计 生物制品评价与研究中心（CBER）1325817161810983% 药物评价与研究中心（CDER）7713135104153% FDA其他部门101001100% 全职等效人员（FTE）总计2107131212815172% BsUFA III 2023财年招聘目标 第一季度 招聘人数* （2022年12月31日） 第二季度 招聘人数* （2023年3月31日） 第三季度 招聘人数* （2023年6月30日） 第四季度 招聘人数* （2023年9月30日） 完成百分比总计 药物评价与研究中心（CDER）143112750% 全职等效人员（FTE）总计143112750% *招聘人数定义为在指定日期前已被确认全职在岗于上述中心的人员。虽然部分招聘人员来自中心/FDA外部，但在某些情况下，招聘人员也可能是当前中心/FDA内部转岗的员工。如CDER与CBER净招聘数据页面所示，CDER尽可能对外招聘新职位。 内容截至日期： 2026年11月05日 监管产品 药品
正文 · 英文原文
PDUFA and BsUFA Quarterly Hiring Updates Prescription Drug User Fee Act (PDUFA VII) and Biosimilar User Fee Act (BsUFA III) Prescription Drug User Fee Amendments As part of the reauthorizations of the Prescription Drug User Fee Act (PDUFA VII) and the Biosimilar User Fee Act (BsUFA III), the Food and Drug Administration (FDA) committed to reporting quarterly updates on the progress made towards hiring goals for fiscal years (FY) 2023-2027. Tables will be added for each FY (2023-2027) below and updated quarterly. For more information on Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) net hiring data in addition to what is reported under PDUFA VII and BsUFA III, see CDER & CBER Net Hiring Data. FY26 Hiring Goals The tables below represent the outstanding hiring goals from FY 2026 for PDUFA VII and FDA’s completion percentage of those hiring goals as of September 30, 2026. PDUFA VIIFY 2026 Hiring GoalsQ1 Hires* (12/31/2025)Q2 Hires* (3/31/2026)Q3 Hires* (6/30/2026)Q4 Hires* (9/30/2026)TotalPercentage Complete Center for Biologics Evaluation and Research (CBER)150002213% Center for Drug Evaluation and Research (CDER)0000000% Other FDA000000%0% TOTAL Full Time Equivalents (FTEs)1500022%13% *A hire is defined as someone who has been confirmed as on board by the date indicated in a full-time position at the noted Center. While some hires are recruited from outside the Center/FDA, in some cases a hire can also be a current Center/FDA employee who is changing positions within the agency. As reflected on the CDER & CBER Net Hiring Data page, CDER recruits for new positions externally to the greatest extent possible. Remaining Hires from FY25 The tables below represent the outstanding hiring goals from FY 2025 for PDUFA VII and BsUFA III and FDA’s completion percentage of those hiring goals as of September 30, 2026. PDUFA VIIFY 2025 Hiring GoalTotal Hires (as of 9/30/2026)Percentage Complete Center for Biologics Evaluation and Research (CBER)291552% Center for Drug Evaluation and Research (CDER)151493% BsUFA IIIFY 2025 Hiring GoalTotal Hires (as of 9/30/2026)Percentage Complete Center for Drug Evaluation and Research (CDER)100% FY25 Hiring Goals The tables below represent the outstanding hiring goals from FY 2025 for PDUFA VII and BsUFA III and FDA’s completion percentage of those hiring goals as of September 30, 2025. PDUFA VIIFY 2025 Hiring GoalsQ1 Hires* (12/30/2024)Q2 Hires* (3/31/2025)Q3 Hires* (6/30/2025)Q4 Hires* (9/30/2025)TotalPercentage complete Center for Biologics Evaluation and Research (CBER)297100828% Center for Drug Evaluation and Research (CDER)157200960% Other FDA0000000% TOTAL Full Time Equivalents (FTEs)44143001739% BsUFA IIIFY 2025 Hiring GoalsQ1 Hires* (12/30/2024)Q2 Hires* (3/31/2025)Q3 Hires* (6/30/2025)Q4 Hires* (9/30/2025)TotalPercentage complete Center for Drug Evaluation and Research (CDER)1000000% TOTAL Full Time Equivalents (FTEs)1000000% *A hire is defined as someone who has been confirmed as on board by the date indicated in a full-time position at the noted Center. While some hires are recruited from outside the Center/FDA, in some cases a hire can also be a current Center/FDA employee who is changing positions within the agency. As reflected on the CDER & CBER Net Hiring Data page, CDER recruits for new positions externally to the greatest extent possible. Remaining Hires from FY24 The tables below represent the outstanding hiring goals from FY 2024 for PDUFA VII and BsUFA III and FDA’s completion percentage of those hiring goals as of September 30, 2026. PDUFA VIIFY 2024 Hiring GoalTotal Hires (as of 9/30/2026)Percentage complete Center for Biologics Evaluation and Research (CBER)483879% Center for Drug Evaluation and Research (CDER)312994% BsUFA IIIFY 2024 Hiring GoalTotal Hires (as of 9/30/2026)Percentage complete Center for Drug Evaluation and Research (CDER)100% FY24 Hiring Goals The tables below represent the outstanding hiring goals from FY 2024 for PDUFA VII and BsUFA III and FDA’s completion percentage of those hiring goals as of September 30, 2024. PDUFA VIIFY 2024 Hiring GoalsQ1 Hires* (12/30/2023)Q2 Hires* (3/31/2024)Q3 Hires* (6/30/2024)Q4 Hires* (9/30/2024)TotalPercentage complete Center for Biologics Evaluation and Research (CBER)48615573369% Center for Drug Evaluation and Research (CDER)3137762374% Other FDA0000000% TOTAL Full Time Equivalents (FTEs)7992212135671% BsUFA IIIFY 2024 Hiring GoalsQ1 Hires* (12/30/2023)Q2 Hires* (3/31/2024)Q3 Hires* (6/30/2024)Q4 Hires* (9/30/2024)TotalPercentage complete Center for Drug Evaluation and Research (CDER)1000000% TOTAL Full Time Equivalents (FTEs)1000000% *A hire is defined as someone who has been confirmed as on board by the date indicated in a full-time position at the noted Center. While some hires are recruited from outside the Center/FDA, in some cases a hire can also be a current Center/FDA employee who is changing positions within the agency. As reflected on the CDER & CBER Net Hiring Data page, CDER recruits for new positions externally to the greatest extent possible. Remaining Hires from FY23 The tables below represent the outstanding hiring goals from FY 2023 for PDUFA VII and BsUFA III and FDA’s completion percentage of those hiring goals as of September 30, 2026. PDUFA VIIFY 2023 Hiring GoalTotal Hires (as of 9/30/2026)Percentage complete Center for Biologics Evaluation and Research (CBER)132132100% Center for Drug Evaluation and Research (CDER)777597% BsUFA IIIFY 2023 Hiring GoalTotal Hires (as of 9/30/2026)Percentage complete Center for Drug Evaluation and Research (CDER)141393% FY23 Hiring Goals The tables below represent the outstanding hiring goals from FY 2023 for PDUFA VII and BsUFA III and FDA’s completion percentage of those hiring goals as of September 30, 2023. PDUFA VIIFY 2023 Hiring GoalsQ1 Hires* (12/31/2022) Q2 Hires* (3/31/2023) Q3 Hires* (6/30/2023) Q4 Hires* (9/30/2023) TotalPercentage complete Center for Biologics Evaluation and Research (CBER)1325817161810983% Center for Drug Evaluation and Research (CDER)7713135104153% Other FDA101001100% TOTAL Full Time Equivalents (FTEs)2107131212815172% BsUFA IIIFY 2023 Hiring GoalsQ1 Hires* (12/31/2022) Q2 Hires* (3/31/2023) Q3 Hires* (6/30/2023) Q4 Hires* (9/30/2023) TotalPercentage complete Center for Drug Evaluation and Research (CDER)143112750% TOTAL Full Time Equivalents (FTEs)143112750% *A hire is defined as someone who has been confirmed as on board by the date indicated in a full-time position at the noted Center. While some hires are recruited from outside the Center/FDA, in some cases a hire can also be a current Center/FDA employee who is changing positions within the agency. As reflected on the CDER & CBER Net Hiring Data page, CDER recruits for new positions externally to the greatest extent possible. Content current as of: 11/05/2026 Regulated Product(s) Drugs