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FDA Drug labeling requirements
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Plain Language Initiative for Labeling
- April 28, 2015
- Posted by: AXSource
- Category: Blog, Regulatory and Quality
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Plain language is a clear writing style designed to be easy to read and understood by the intended audience. The plain language initiative of Health Canada is intended to ensure that information on labels can be easily understood by the target audience. Health Canada will evaluate plain language for drugs for human use through several
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Drug Compounding & US FDA Regulatory Compliance
- November 10, 2014
- Posted by: AXSource
- Category: Blog, Regulatory and Quality
Compounded drugs made using poor quality practices may be sub- or super‑potent, contaminated, or otherwise adulterated. While compounding under poor quality practices has been previously associated with adverse events, the compounding industry remained opposed to Food & Drug Association (FDA) regulatory oversight on compounding drug practices (1). It was the 2012 fungal meningitis outbreak (750
