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.

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 December 31, 2022.

PDUFA VII	FY 2023 Hiring Goals	Q1 Hires* (12/31/2022)	Q2 Hires*	Q3 Hires*	Q4 Hires*	Total	Percentage complete
Center for Biologics Evaluation and Research (CBER)	132	58**	-	-	-	58	44%
Center for Drug Evaluation and Research (CDER)	77	13**	-	-	-	13	17%
Other FDA	1	0	-	-	-	0	0%
TOTAL Full Time Equivalents (FTEs)	210	71	-	-	-	71	34%

BsUFA III	FY 2023 Hiring Goals	Q1 Hires* (12/31/2022)	Q2 Hires*	Q3 Hires*	Q4 Hires*	Total	Percentage complete
Center for Drug Evaluation and Research (CDER)	14	3	-	-	-	3	21%
TOTAL Full Time Equivalents (FTEs)	14	3	-	-	-	3	21%

*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.

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