Tag: FDA
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What New Diagnostic Tools and Drugs have Emerged as Interesting in 2024,
Part IV In our last post of the series about what is new in 2024, now that it is 2025, we will look at what…
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After the Original PSA Test Approvals, Where Do We Go Next?
We have explored the first 2 PSA Test FDA Approvals, as difficult as it may be to understand how they got an approval. But they…
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The Second FDA approved PSA Test
Hybritech was determined to get its PSA test approved by the FDA for expanded uses; rather than continuing to have physicians to use the test…
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Catching Up for Instagram and Facebook
I have now tied my Facebook and Instagram accounts to this blog. My hope was to be able to create simple posts and put them…
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Mea Culpa
In an earlier post, I made a mistake. Based on an exchange of emails back in 2015 or 2016 with Dr. Richard Ablin, I said…
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How Did the First Prostate Specific Antigen (PSA) Test get FDA Approval
For medical devices (Class I and II), to gain FDA approval, the device must be deemed SAFE and EFFECTIVE. This is done via a 510(K)-approval…
