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SQA Regulatory Surveillance Summary | Monthly Update 2022 – September/October

SQA

This proposal builds upon the existing legal framework, which came into force in 2002 for blood and 2004 for tissues and cells. United States Food and Drug Administration (FDA) – Regulations and guidance. The FDA is issuing this guidance to provide clarity and predictability for software manufacturers on this topic.

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SQA Regulatory Surveillance Summary | Monthly Update 2023 – July and August 2023

SQA

The US FDA has already recognized the ability of 16 EU Member States to conduct GMP inspections of manufacturers of veterinary medicinal products. At the same time, the EU has recognized the US FDA as an equivalent authority to carry out these inspections.

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