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GxP Lifeline

Showing items tagged as The Food and Drug Administration Safety and Innovation Act (FDASIA)

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    The Quality Metrics Journey

    One of the most discussed and debated topics on today’s pharmaceutical landscape is the issue of quality metrics. Establishing, maintaining, and interpreting quality metrics to determine the suitability of pharmaceutical products has become a high priority for the FDA. To understand the issue of quality metrics it is important to start at the beginning.

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  • Brave New World: The Mutual Recognition of CGMP Inspections

    Last week, the United States and the European Union agreed to recognize each other’s drug cGMP inspections. The agreement reached (see

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