Tag Archive: regulations

May 02 2012

Across the Board Disqualifications for Clinical Investigators

The FDA issued a final regulation earlier this week (April 30th) that broadens the rules for clinical investigator disqualifications.

Jan 17 2011

New Informed Consent Requirements Improve Transparency in Clinical Trials

Trust, honesty, humility, transparency and accountability are the building blocks of a positive reputation. Trust is the foundation of any relationship. – Mike Paul Transparency of clinical research to participants and patients is what the FDA is going for with their amended informed consent regulations. The new regulations stem from the Food and Drug Administration …

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Apr 29 2010

FDA Warning Letters vs Untitled Letters

History is a vast early warning system. – Norman Cousins The Drug and Device Law blog recently published two short posts on FDA warning letters.  The first post mistakenly described an untitled letter, referenced in a lawsuit, as a warning letter.  The second corrects the mistake and then gives a nice description of the difference …

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