2011 Blog FDA Informed Consent 
SQA
FEBRUARY 15, 2023
” The reason: The existing document of the EU GMP Guideline dates back to 2011 and no longer corresponds to the state of the art in various areas or does not consider increasingly important new technologies for the GMP field, according to the EMA. ” The requirements for providers (e.g.,
Drug & Device Law
DECEMBER 29, 2023
This year’s Drug & Device Law Blog top ten decisions of the year reinforced preemption – the most powerful defense we can assert. Instead, Zofran turned mainly on animal studies – three Japanese studies that were not “newly acquired information” that could avoid preemption. They excluded bogus expert testimony under Fed.
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