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- Gene therapy sponsors urged to address six GMP manufacturing considerations earlySK pharmteco’s chief technical officer Tatiana Nanda explained that gene therapy sponsors need to think about manufacturing issues well before reaching GMP production. She told BioSpace that early…
- FDA reduces required analytical tests for emergency-use diagnostic devicesThe FDA finalized new guidance aimed at streamlining validation for in-vitro diagnostic (IVD) devices that detect emerging pathogens during public-health emergencies. The guidance lowers the numbe…