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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. It also fosters innovation in this crucial biotech sector. The framework contains parallel provisions for donor selection, quality and safety management and oversight.

FDA 40
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SQA Regulatory Surveillance Summary | Monthly Update 2024

SQA

These are requirements of the Therapeutic Goods (Medical Devices) Regulations 2002. World Health Organization (WHO) Medical Product Alert N°7/2023: Falsified DEFITELIO (defibrotide), 04 September 2023 This WHO Medical Product Alert refers to one falsified batch of DEFITELIO (defibrotide sodium).

FDA 52