All pharmaceutical articles
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Blog post
Pharmacy compliance director pleads guilty over mislabeled drugs
The former director of compliance for a compounding pharmacy company pleaded guilty last week to introducing adulterated drugs into interstate commerce and conspiracy to defraud the United States by obstructing the Food and Drug Administration’s lawful functions.
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Blog post
McKesson to pay $150M in prescription drug probe
Drug distributor McKesson will pay a record $150 million civil penalty for alleged violations of the Controlled Substances Act, the Justice Department announced today. The settlement also imposes new and enhanced compliance obligations, as well as an independent monitor—the first independent monitor of its kind in a CSA civil penalty ...
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Article
European Medicines Agency issues data integrity guidance
The pharmaceutical industry faces fresh regulatory pressure around the world over data integrity issues, reports Jaclyn Jaeger, particularly involving clinical trials.