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Ice is roughly 9% less dense than liquid water, according to the US Geological Survey, so water takes up more room as it freezes. Inside a sealed pipe or a water-filled line left in an unheated building, that extra volume has...


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Lonza has signed a definitive agreement to acquire five US manufacturing sites from Merck KGaA, Darmstadt, Germany, adding capacity in antibody–drug conjugate (ADC) manufacturing, viral vector production, high-potency active pharmaceutical ingredient (HPAPI) payload synthesis...


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US clinical laboratories and sequencing facilities sourcing instruments, reagents, or consumables from BGI Genomics Co., MGI Tech Co., or the Shenzhen BGI Technology Co., now face an immediate import prohibi...


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A cream that moisturizes dry skin and a cream that relieves eczema itch can share a base formula. Under US law, they belong to different regulatory categories. The claims on the label and in marketing decide which rules apply and which evidence carries weight. In vitro skin permeation testing sits at the center of all three categories. Formulators use Franz diffusion...


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Outsourced Testing, Retained Liability: Why Does Contract Lab Qualification Matter to the FDA?

The FDA holds the product owner responsible for every result a contract lab generates. In its


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