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Posted by Sandra Maddock on Wed, Mar 04, 2015

FDA Audit Prep

You’ve received “the call” from the FDA auditor.  After an understandable quick moment of panic, what should your next steps be?

Topics: Warning Letter, Audit Prep, BIMO Checklist, FDA

Posted by John Lehmann on Wed, Mar 04, 2015

FDA Cracking Down- Be Careful What you “Like”

For some it’s hard to remember life before the internet. Having access to endless amounts of “resources” and knowledge, instant “friends” with those thousands of miles away, and the ability to always be in-step with those you “follow”- all have revolutionized the modern day world. Recent warning letters issued by FDA urge the industry to take cautionary steps when navigating this new World Wide Web frontier.

Topics: Warning Letter, social media, FDA

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Clinical Research Training Requirements
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