Remove category life-sciences
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SQA Regulatory Surveillance Summary | Monthly Update 2022 – September/October

SQA

The 20-page Q&A document covers general and specific topics including the importation of cannabis products, simplified authorization procedures for education, and research institutions that are conducting cannabis studies using real-life data. 26 of 2014. United States Food and Drug Administration (FDA) – Regulations and guidance.

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

Health Law Advisor

But the question is, to what extent do health care providers need to worry about FDA requirements as they use AI? FDA has been regulating machine learning algorithms used in a clinical context for decades. It’s important to understand that FDA regulation isn’t punitive in the sense that it’s only intended to apply to bad people.

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