FDA official tells CGT developers to leverage multiple meeting opportunities with agency
Regulatory NewsJoanne S. Eglovitch
Advanced therapies/cell and gene therapyBiologics License Application (BLA)Breakthrough devices programCBERCDERClinical TrialsEthics/Professional ConductGCPHuman cells, tissues, and cellular and tissue-based products (HCT/Ps)Preclinical studyQuality Assurance and ControlRegulatory Intelligence/PolicyUnited States