CBER Review Management Improvement Includes Focus On Data Harmonization
This article was originally published in The Pink Sheet Daily
CBER's "Managed Review Process" paired with CDISC contract.
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One Trial Plus Supportive Evidence Is Enough For Hospital-, Ventilator-Acquired Pneumonia Indication, Panel Says
Anti-Infective Drugs Advisory Committee members viewed one-trial as practical means of gaining efficacy data.