Welchol Investigator Gets FDA Warning Letter
This article was originally published in The Pink Sheet Daily
Thomas O'Barr, principal investigator with Sestron Clinical Research, failed to keep adequate records, FDA says.
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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.