New draft guidance issued by the US Food and Drug Administration (FDA) is intended to clarify which changes to a pharmaceutical company's manufacturing process must be reported to federal regulators, ...
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Tiny 3D-printed nozzles could be a big deal for drug and self-healing material manufacturing
A new 3D-printed fabrication approach means a cleanroom is now optional ...
From the moment we could look up to the skies, humanity has dreamt of what’s up there. And once we got there, how could we master it? And now that we’re there all the time, how can we use it? In 2025, ...
Advancements in drug manufacturing technologies are reshaping global regulatory frameworks. This shift is largely driven by the integration of artificial intelligence (AI)-powered models, cloud-based ...
UK-based BioOrbit, which aims to manufacture drugs in space using microgravity, has raised £9.8 million ($13.2 million) in seed funding. The round was co-led by LocalGlobe and Breega, with ...
Researchers at the University of Liège (BE) have designed a high-performance, open-access continuous flow process to safely produce key antibacterial drugs from bio-based furfural. The results of the ...
A Class II recall was initiated for duloxetine lots after N-nitroso-duloxetine exceeded FDA intake limits, reflecting low acute clinical risk but regulatory nonconformance. Nitrosamine issues ...
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