Standard of Care vs State-Of-The-Art

They are not the same thing at all. Or are they? The FDA may think so, and it can impact

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The Do’s and Don’ts of FDA Submission Pathways

As a certified regulatory grief counselor, I am asked about FDA submission pathways all the time. These questions typically come

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MDD vs. MDR – The Debate Rages On

I am pretty thick-skinned and not easily flustered. But few things get me as agitated as the ongoing debate over

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