PRISM Identifies Vaccine Safety Issues
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PRISM is a computer-based vaccine safety monitoring system that sifts out critical information
FDA: Helping Small Businesses Get Big Results
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Small companies have a significant impact on U.S. made pharmaceuticals
It is well known that small business is vital to the success of the U.S. economy. Less known, though, is how instrumental it has been to the growth and innovation in drug development.
Inside Quality Digest Live for April 14, 2017
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Expect to see e-skin devices in the near future
Credit: University of Tokyo, School of Engineering
On our most recent episode of QDL from this past Fri., April 14, 2017, we took a close look at innovation and engineering. Here’s a quick recap:
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.
