category artificial-intelligence 
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.,
Health Law Advisor
AUGUST 10, 2023
5] But that Interstate Commerce Clause needs to be viewed also in balance with the 10th Amendment of the Constitution, which reserves to the states any powers not delegated to the federal government. 1] FDA, Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices, available at [link]. [2] 3] 21 U.S.C.
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