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A trade group representing combination drug products is urging the FDA to draw bright lines among the agency’s centers as it considers voluntary quality standards. Read More
The Senate will weigh another three bills aimed at lowering drug prices in what is turning out to be a frenetic session for the drug industry. Read More
The investigator also found that the firm didn’t conduct dynamic smoke studies for all equipment and components to prove the air flow patterns of critical areas. Read More
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