FDA's Oncology Center of Excellence, its new face for oncology drug development, is now officially on the agency organization chart.
OCE is on par with Center for Drug Evaluation and Research (CDER), as well as the biologics and device centers,...
FDA's Oncology Center Of Excellence On Equal Terms With CDER In New Org Chart
While OCE has a lofty status, it has yet to gain a large cadre of staff.
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Just a week and a half into his tenure at the agency, the new CDER Director George Tidmarsh was also tapped to serve as acting head of CBER. Prasad’s swift ouster at CBER may point to a softening in cell and gene therapy regulation but could also portend even more scrutiny on vaccines.
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The ups – and some downs – of the US FDA’s prescription, biosimilar, and generic user fees for FY 2026 are tabulated by the Pink Sheet.
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The removal of CBER Director Prasad comes after a wave of right-wing backlash to his appointment over the past few days that was also critical of his decision to ask Sarepta to suspend all sales of the DMD gene therapy Elevidys. FDA reversed its decision the day before Parsad's departure.
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The FDA recommended removal of a voluntary hold on shipments of the gene therapy to younger patients after finding that the death of an 8-year-old boy in Brazil was unrelated to Elevidys. Discussions on safety of DMD treatment for non-ambulatory patients is ongoing.