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The antitrust division of the Justice Department has issued subpoenas to a Mylan executive and certain employees over the pricing of four generic drugs. Read More
The French National Agency for Medicines and Health Products Safety (ANSM) released a statement alleging serious violations of good manufacturing practices at Nandu Chemicals Industries, an India-based API maker. 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
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