Dr. Richard Lostritto – A Brief Overview of the Drug Review Process at the Food and Drug Admin
Dr Lostritto Talked about the Center for Drug Evaluation and Research within the FDA. The CDER evaluates new drugs and generics ( to make sure they are equivalent. ). The CDER mission is to protect public health, approve drugs, give oversight and regula-tions,safety, drug industry gui-dance,and provide global in-spection teams. CDER drug approvals go through 3 pha-ses: (1) Pre-clinical Research; (2) Clinical studies on humans; and (3) New Drug Application (NDA). The review includes the drug, enclosure, labeling, and contract.