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.

FDA entrance sign 2016
FDA and industry representatives are preparing for PDUFA reauthorization talks to begin this fall. • Source: File photo

The bright lights of the prescription drug user fee program may be ready to shift more toward the US Food and Drug Administration’s biologics center.

Multiple industry and stakeholder groups indicated that a tidal wave of work is bearing down on the Center for Biologics...

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