Dr. Richard Lostritto – A Brief Overview of the Drug Review Process at the Food and Drug Admin
Posted on September 26th
![Dr. Richard Lostritto – A Brief Overview of the Drug Review Process at the Food and Drug Admin](https://nbrotary.org/wp-content/uploads/2013/09/rLostritto.jpg)
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.
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