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According to FDA, the updated guidelines will replace the initial 2011 draft. It introduces a broader approach to potency and quality monitoring of CGT throughout their development and manufacturing

The recalls of the StatStrip glucose meters by Nova Biomedical and HemosIL AcuStar assay by Werfen have raised issues regarding patient identification and providing false negatives

The new framework clarifies when companion app content is considered drug labelling, when apps belong in Prescribing Information, and what sponsors must submit to the agency

FDA-approved Hibsago (Bepirovirsen) is a first-of-its-kind drug for treating chronic hepatitis B virus (HBV) infection

4 Lots of Edwards Lifesciences delivery systems used in transcatheter mitral valve replacement were recalled after reported death and injury

Maharashtra FDA suspends Sodexo India Services’ license after finding fungus, cockroaches, and rusted knives in the hospital kitchen