From Concept to Regulatory Drug Approval: Lessons for Theranostics
Marlon Perera, Michael J. Morris
Abstract
Learning Objectives: On successful completion of this activity, participants should be able to (1) describe an overview of the FDA approval process, including data required for FDA application; (2) consider the difficulties and hurdles of FDA approval for therapies relating to prostate cancer and radiopharmaceuticals; and (3) recognize that despite these difficulties, recent FDA approval of radiopharmaceuticals in prostate cancer has occurred, specifically for 223 Ra and 177 Lu-PSMA-617.
Topics & Concepts
Drug approvalDrugMedical physicsRegulatory sciencePharmacologyMedicineRisk analysis (engineering)PathologyStatistical Methods in Clinical TrialsPharmaceutical studies and practicesHealth Systems, Economic Evaluations, Quality of Life