Industry Lauds, Worries About FDA Hiring Going Forward
Pfizer's Honig says that as the US FDA adds more employees or fills vacant positions, focus needs to be on training.
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With cell and gene therapies becoming more popular, CBER Director Marks says in an interview with the Pink Sheet that more staff may be needed soon.
In another sign of the increasing influence of generics within FDA, CDER Director Woodcock moves the formal dispute resolution program out of the Office of New Drugs.
Three-to-five year timeline needed to develop algorithms does not engender confidence that new version of formula, which historically pushed user fee rates higher, will be ready before PDUFA VII begins.