Remove category artificial-intelligence
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SQA Regulatory Surveillance Summary | Monthly Update 2023 – March And April

SQA

Having analyzed over 2000 responses received, the government will now take forward legislation to reform of the UK clinical trials regulatory framework that will: Ensure patients and their safety are at the focus of all clinical trials and bring the benefits of clinical trials to everyone.

FDA 40
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FDA Oversight of AI Software Developed by Health Care Providers

Health Law Advisor

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] 7, 2002), at 21. [16]

FDA 98
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SQA Regulatory Surveillance Summary | Monthly Update 2024

SQA

The products had been improperly regularized in ANVISA as cosmetics since they are indicated for injectable use, a form that is not authorized for this category of product. The purpose of the note is to clarify that products for invasive aesthetic treatments cannot be regularized in the category of cosmetics.

FDA 52