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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The Center for Biologics Evaluation and Research may need more fee revenue to add employees to handle the increasing cell and gene therapy workload.
FDA seeks expert comments during an upcoming public meeting on strategies to facilitate various centers combining and sharing data.