FDA official: Agency ironing out the details of plausible mechanism pathway
Regulatory NewsJoanne S. Eglovitch
Advanced therapies/cell and gene therapyBiologics License Application (BLA)Biologics/ biosimilars/ vaccinesCBERCDERExpedited pathwaysPersonalized medicinePharmaceuticalsProduct developmentRegulatory Intelligence/PolicyUnited StatesUS Food and Drug Administration (FDA)