PDUFA and BsUFA Quarterly Hiring Updates

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.

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 December 31, 2024.

PDUFA VII	FY 2025 Hiring Goals	Q1 Hires* (12/31/2024)	Q2 Hires* (3/31/2025)	Q3 Hires* (6/30/2025)	Q4 Hires* (9/30/2025)	Total	Percentage Complete
Center for Biologics Evaluation and Research (CBER)	29	7**	--	--	--	7	24%
Center for Drug Evaluation and Research (CDER)	15	7	--	--	--	7	47%
Other FDA	0	0	0	0	0	0	0%
TOTAL Full Time Equivalents (FTEs)	44	14	--	--	--	14	32%

BsUFA III	FY 2025 Hiring Goals	Q1 Hires* (12/31/2024)	Q2 Hires* (3/31/2025)	Q3 Hires* (6/30/2025)	Q4 Hires* (9/30/2025)	Total	Percentage Complete
Center for Drug Evaluation and Research (CDER)	0	0	0	0	0	0	0%
TOTAL Full Time Equivalents (FTEs)	0	0	0	0	0	0	0%

*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.

**Totals include some PDUFA VII hiring completed prior to FY 2025.

Remaining Hires from FY24

The tables below represent the outstanding hiring goals from FY24 for PDUFA VII and BsUFA III and FDA’s completion percentage of those hiring goals as of December 31, 2024.

PDUFA VII	FY 2024 Hiring Goal	Total Hires (as of 12/31/2024)	Percentage Complete
Center for Biologics Evaluation and Research (CBER)	48	35	73%
Center for Drug Evaluation and Research (CDER)	31	27	87%

BsUFA III	FY 2024 Hiring Goal	Total Hires (as of 12/31/2024)	Percentage Complete
Center for Drug Evaluation and Research (CDER)	1	0	0%

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 VII	FY 2024 Hiring Goals	Q1 Hires* (12/30/2023)	Q2 Hires* (3/31/2024)	Q3 Hires* (6/30/2024)	Q4 Hires* (9/30/2024)	Total	Percentage complete
Center for Biologics Evaluation and Research (CBER)	48	6**	15	5	7	33	69%
Center for Drug Evaluation and Research (CDER)	31	3**	7	7	6	23	74%
Other FDA	0	0	0	0	0	0	0%
TOTAL Full Time Equivalents (FTEs)	79	9	22	12	13	56	71%

BsUFA III	FY 2024 Hiring Goals	Q1 Hires* (12/30/2023)	Q2 Hires* (3/31/2024)	Q3 Hires* (6/30/2024)	Q4 Hires* (9/30/2024)	Total	Percentage complete
Center for Drug Evaluation and Research (CDER)	1	0	0	0	0	0	0%
TOTAL Full Time Equivalents (FTEs)	1	0	0	0	0	0	0%

*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.

**Totals include some PDUFA VII hiring completed prior to FY 2024.

Remaining Hires from FY23

The tables below represent the outstanding hiring goals from FY23 for PDUFA VII and BsUFA III and FDA’s completion percentage of those hiring goals as of December 31, 2024.

PDUFA VII	FY 2023 Hiring Goal	Total Hires (as of 12/31/2024)	Percentage complete
Center for Biologics Evaluation and Research (CBER)	132	130	98%
Center for Drug Evaluation and Research (CDER)	77	69	90%

BsUFA III	FY 2023 Hiring Goal	Total Hires (as of 12/31/2024)	Percentage complete
Center for Drug Evaluation and Research (CDER)	14	13	93%

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 VII	FY 2023 Hiring Goals	Q1 Hires* (12/31/2022)	Q2 Hires* (3/31/2023)	Q3 Hires* (6/30/2023)	Q4 Hires* (9/30/2023)	Total	Percentage complete
Center for Biologics Evaluation and Research (CBER)	132	58**	17	16	18	109	83%
Center for Drug Evaluation and Research (CDER)	77	13	13	5	10	41	53%
Other FDA	1	0	1	0	0	1	100%
TOTAL Full Time Equivalents (FTEs)	210	71	31	21	28	151	72%

BsUFA III	FY 2023 Hiring Goals	Q1 Hires* (12/31/2022)	Q2 Hires* (3/31/2023)	Q3 Hires* (6/30/2023)	Q4 Hires* (9/30/2023)	Total	Percentage complete
Center for Drug Evaluation and Research (CDER)	14	3	1	1	2	7	50%
TOTAL Full Time Equivalents (FTEs)	14	3	1	1	2	7	50%

*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.

**Totals include some PDUFA VII hiring completed prior to FY 2023.