FDA warning letters address CGMP, clinical study plan failures
Regulatory NewsJoanne S. Eglovitch
Biologics/ biosimilars/ vaccinesBiotechnologyCompliancePharmaceuticalsQuality Assurance and ControlRegulatory Intelligence/PolicyUnited StatesRegulatory NewsJoanne S. EglovitchBiologics/ biosimilars/ vaccinesBiotechnologyCompliancePharmaceuticalsQuality Assurance and ControlRegulatory Intelligence/PolicyUnited States