Armed with evidence from a recent study of latex allergy skin reactions in patients, scientists at Johns Hopkins encourage the Food and Drug Administration (FDA) and drug makers to label all current ...

Final product inspection results should be included as part of the batch release documentation, says Susan J. Schniepp, distinguished fellow at Nelson Laboratories, LLC. A: This is not a new problem ...

Hospira announced a voluntary nationwide recall of one lot of Marcaine (bupivacaine HCl) injection, 0.25%, 75mg/30mL, after a confirmed report of discolored solution with visible particles inside the ...

Heike Kofler, Manager, Technical Customer Support EU, West Pharmaceutical Services, elaborates on why pharma companies are increasingly turning to lyophilising in order to preserve the characteristics ...

Biotechnology promises treatments for many diseases previously thought to be intractable. Despite a significant effort at delivering biotherapeutics, peptides, and proteins through nontraditional ...

To properly inspect based on measurement, a reference standard is crucial for comparison. "The production inspectors looked at each vial three times. That is, they did three 100% inspections. How can ...

Pharmaceuticals major Dr Reddy's Laboratories has recalled a single lot of Docetaxel injection vials, used for treatment of breast cancer, USFDA has said. As per the US health regulator's enforcement ...