Tougher Quality Management Enforcement Possible by FDA
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The FDA will have more funding to do its job—including more inspections of life sciences manufacturers
Quality management, always an FDA focus during inspections, could become even more important in 2017 as FDA priorities take shape.
Key Challenges for Risk Management in Medical Device Development
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Risk management is a full life-cycle activity for medical device development
The FDA Mutual Reliance Initiative
For FDA professionals focused on drug quality and safety, the rapid increase in imported drugs from nations where we devote limited inspection resources is of great concern.