FDA’s Breakthrough Designation Now Includes Health Equity Provision
Though not expected to drastically change the program, new component gives device makers another way to strengthen their submissions
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Advancements in Antimicrobial Susceptibility Testing: Part 2
Several methods are being developed that improve the ability to rapidly identify organisms and report susceptibility results.
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Advancements in Antimicrobial Susceptibility Testing: Part 1
A brief overview of antimicrobial susceptibility testing, current methods used, and new methods on the horizon.
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Profiling Pathogens for Public Health
Genomic epidemiology can provide insights into pathogen transmission and evolution—and facilitate better countermeasures against infectious disease.
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The Diagnostics Pipeline: FDA Moves to Modernize 510(k) Process for New Lab Tests & Devices
The changes proposed in three new draft guidances aim to speed up the process and place less emphasis on older predicate products.
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