Copley Scientific

Activities: Regulatory Analysis

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  2. FDA issues first cGMP warning letter citing AI misuse in pharmaceutical manufacturing A Michigan-based lab has become the subject of the FDA's first dedicated enforcement action on artificial intelligence misuse in drug manufacturing — a landmark event with...
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    Inhaled therapies advance as clinical trial data signal progress on two respiratory fronts Two separate clinical programmes have reported encouraging progress in the development of inhaled therapies for respiratory conditions, with positive data emerging from trials...
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    MC EXCLUSIVE: MHRA on a mission to redefine UK gene therapy The UK's medicines regulator is seeking industry input on a landmark overhaul of gene therapy medicinal product definitions — the first substantive update in more than two...
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