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Rhonda Alexander, MS, MPA
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Join date: Feb 15, 2021
Posts (4)
Jan 30, 2018 ∙ 3 min
FDA Publishes Final Refuse To Accept Guidance
Today, FDA released the final version of its guidance document, relating to its Refuse to Accept (RTA) policy. The document, “Refuse to...
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Nov 14, 2017 ∙ 1 min
Final Guidance Documents: When to submit new 510(k)s for devices and software
FDA has issued final guidance documents to help medical device companies determine when to submit new 510(k)s for hardware and software....
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Sep 5, 2017 ∙ 1 min
GDUFA REAUTHORIZED FOR 2018
On August 18, 2017, the Food and Drug Administration Reauthorization Act (FDARA) was signed into law, which includes the reauthorization...
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