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The FDA and Brigham and Women’s Hospital are expanding a demonstration project with Aetion to use real-world evidence (RWE) to predict the results of seven ongoing Phase IV trials. Read More
An Indianapolis jury convicted the former CEO of a Noblesville, Indiana drug compounder of conspiracy to defraud the FDA and multiple counts of drug adulteration—including some over-potent children’s drugs shipped to hospitals. Read More
The drug industry is asking the FDA for more clarity around whether or not natural histories should be included in rare disease trials—and two of the nation’s largest drug trade groups appear to be at odds over the issue. Read More
The Trump administration has ordered federal agencies—including the FDA—to submit all pending guidance documents to the White House budget office, a move that some experts say could stall drug policy changes. Read More