Remove category artificial-intelligence
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SQA Regulatory Surveillance Summary for May and June 2024

SQA

Most synthetic injectable peptides are regulated as prescription drugs in Canada and require a prescription from a licensed healthcare professional. 68: Risk-Based Approach for Prevention and Management of Drug Shortages was originally developed in 2014. Some peptides can be produced for use in medications.

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SQA Regulatory Surveillance Summary | Monthly Update 2023 – March And April

SQA

The company did not have a written procedure in place for the provision of information related to serious risk of injury to health, contrary to what was committed to on it establishment license application. The name and address of manufacturers provided by the company on its establishment license application were not accurate.

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

Health Law Advisor

FDA specifically identified the following as not having to register as device manufacturers: Licensed practitioners, including physicians, dentists, and optometrists, who manufacture or otherwise alter devices solely for use in their practice. [8] 8] We could go on, but hopefully you get the gist.

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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.

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