US FDA's Abernethy 'Cautious' About Real-World Evidence
FDA's principal deputy commissioner, who used to work in the real-world evidence field, said momentum is building, but more successful use cases are needed.
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Agency officials determining needs using existing budgets before requesting more funds and will engage with tech investors for design advice.
CDER-based program lead by Marta Sokolowska will also handle benzodiazepine and stimulants activities and consult on relevant application assessments.
The Center for Biologics Evaluation and Research may need more fee revenue to add employees to handle the increasing cell and gene therapy workload.