FDA leaders propose new ‘plausible mechanism’ pathway for bespoke medicines
Regulatory NewsJoanne S. Eglovitch
Advanced therapies/cell and gene therapyApproval/marketing authorizationBiologics/ biosimilars/ vaccinesBiotechnologyCBERCDERPersonalized medicinePharmaceuticalsProduct developmentRegulatory Intelligence/PolicyRWE/RWDUnited StatesUS Food and Drug Administration (FDA)