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Kazakhstan to undergo PIC/S on-site assessment in 2027

Kazakhstan has been approved for an on-site assessment mission and an observed inspection in 2027 as part of its...
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China’s revised medical device GMP takes effect, strengthening quality and contract manufacturing requirements

China’s National Medical Products Administration (NMPA) put its revised Good Manufacturing Practice (GMP) for Medical Devices into effect on...
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FDA proposes framework for individualized gene therapies as CMS expands access

The US Food and Drug Administration (FDA) has proposed a regulatory framework for individualized human genome editing therapies, while...
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