Tag Archive: enforcement action

Oct 10 2012

Clinical Trial Reporting

On 26 September 2012, a notice was published in the Federal Register that the Department of Health and Human Services was transferring responsibility to the FDA for ensuring that clinical trial data is appropriately submitted to Clinical Trial Registry and Results Data Bank (which is also known as ClinicalTrials.gov) and that the data is complete …

Continue reading »

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 …

Continue reading »