BioCentury analysis quantified a recent staffing drain at the FDA—reporting that one in seven CBER and one in eight CDER employees exited in fiscal Q4—raising concerns about the agency’s capacity amid a complex drug and device pipeline. The data point to operational strain in review centers handling biologics and drugs. A separate BioCentury piece criticized the FDA’s national priority voucher program as potentially ‘picking winners and losers,’ arguing the incentive structure may reward some sponsors disproportionately and distort resource allocation. Industry stakeholders warned the combination of staffing pressures and shifting incentive policies could slow review timelines and complicate enforcement priorities. Policy observers said watching how the agency reallocates internal resources and adjusts program rules will be critical for sponsors planning near‑term submissions.
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