Industry suggests changes to FDA’s CMC readiness pilot
Regulatory NewsJoanne S. Eglovitch
Biologics License Application (BLA)Biologics/ biosimilars/ vaccinesBiotechnologyCBERCDERChemistry, Manufacturing and Controls (CMC)ManufacturingPharmaceuticalsQuality Assurance and ControlRegulatory Intelligence/PolicyRegulatory strategyUnited StatesUS Food and Drug Administration (FDA)