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Industry proposals to loosen regulations on off-label communication neglect to provide a comprehensive framework for the FDA to monitor unapproved uses, leaving the agency to wonder where boundaries should be drawn. Read More
The FDA is revising the list of drug products that have been banned or removed from the market for safety or effectiveness reasons and so cannot be used in compounding. Read More
The European Medicines Agency is investigating reports that India’s Wanbury Pharma, one of the largest exporters of the diabetes drug metformin, had more than half of its exports produced by an unlicensed supplier. Read More