FDA grapples with infant PPI study challenges
This article was originally published in Scrip
When AstraZeneca, Pfizer and Takeda, which had been asked by the FDA to conduct trials of their proton-pump inhibitors (PPIs) for treating gastroesophageal reflux disease (GERD) in infants, presented their results, the agency knew it had a problem. None of the trials showed the drugs to be effective. Consequently, the FDA convened a panel of outside experts on 5 November to advise on what it should do next.
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