US FDA's Biologics Center May Get Its Day In PDUFA VII
Multiple stakeholders call for CBER to receive more prescription drug user fee funds amid growing cell and gene therapy popularity.
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Talks between US FDA and industry to extend the generic drug and prescription drug user fee programs may last into 2021.
The agency sees its personnel compensation and benefits costs decrease for the first time in at least 16 years, while the overall FTE count continues to rise.
As outside report urges increased planning and culture changes, FDA OTS Director Keller says recruitment will stop ‘order taking’ and move to ‘forecasting the hiring needs of each of the centers.’