Neil Flanzraich of Cantex Pharmaceuticals, Inc., outlines the various approaches that the U.S. Food and Drug Administration (FDA) uses to review new drug applications. He describes how the standards for approval have changed over the years, and what that means for pharmaceutical companies. For example, in order to quicken access to promising new therapies, accelerated review is now possible, provided that protocols are in place for post-market surveillance. In Flanzraich's view, some accommodations, such as the Breakthrough Product Designation, benefit drug companies differentially, with larger firms being much more able to demonstrate effectiveness in early clinical trials.
This video is by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School
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