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FDA Seeks Comment On Considerations For Externally Controlled Trials For Drugs Biologics

On Feb. 1, 2023, the FDA released a new guidance, "Considerations for the Design and Conduct of Externally Controlled Trials for Drug and. ....

Dianne Paraoan , Mark Durivage , Office Of Communication , Drug Administration , Quality Systems Compliance , Externally Controlled Trials , Dockets Management Staff ,