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Daily Archives: Nov 10, 2026

Discover all articles written based on the date that they were written. An online archive that can be browsed at your leisure.

Kazakhstan to undergo PIC/S on-site...

Kazakhstan has been approved for an on-site...

China’s revised medical device GMP...

China’s National Medical Products Administration (NMPA) put...

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

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China’s revised medical device GMP takes effect, strengthening quality and contract manufacturing requirements

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FDA proposes framework for individualized gene therapies as CMS expands access

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Clopidogrel oral liquids recall: assay control, OOS investigation and batch impact assessment

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FDA inspections: who will inspect your site — and who decides the outcome?

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UK announces AI Biosecurity Lab with up to £300 million in public and industry support

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Who will inspect your pharmaceutical site? A guide to the global GMP inspection landscape

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Council of Europe proposes regulatory framework for human organs manipulated ex situ

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Baxter Warning Letter highlights systemic weaknesses in contamination control

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UK government confirms indefinite recognition of CE-marked medical devices

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Remote Russian GMP inspections: interpreter insights on preparation, documentation and conduct

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MHRA outlines AI and MedTech regulatory plans at AdvaMed 2026

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EMA opens consultations on confirmatory platform trials and pharmacovigilance data quality

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AI in drug development: ten principles for data integrity, validation and lifecycle oversight

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PIC/S updates qualification and validation guidance: PI 006-4 now in force

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FDA, Sanofi and Gilead discuss AI data readiness and risk-based validation

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EU veterinary GMP regulations take effect, requiring quality-system reviews

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European Commission grants €10 million to EMA to support the African Medicines Agency

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Sanofi agrees to acquire Inhibrx, adding rare disease candidate to its portfolio

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PlaqueTec and Babraham Institute partner on CAD blood study

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