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Cautionary Tales

Last week on LinkedIn, I shared a recently issued FDA Warning Letter that generated a lot of views and ‘likes.’ The topic of the...

Recently Published Guidance from the FDA

There have been a number of draft and final guidance documents published by the US Food and Drug Administration (FDA) in the past several...

Knock, Knock

I often emphasize that the FDA website has a wealth of publicly available information related to regulatory compliance, clinical research...

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