Recent CBER warning letters target unapproved products, BIMO violations
Regulatory NewsJoanne S. Eglovitch
Approval/marketing authorizationAudit/inspectionBiologics/ biosimilars/ vaccinesCBERComplianceGMPHuman cells, tissues, and cellular and tissue-based products (HCT/Ps)PharmaceuticalsQuality Assurance and ControlRegulatory Intelligence/PolicyUnited StatesUS Food and Drug Administration (FDA)Warning letters