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Sponsored Projects Administration

If Everyone Hates the FDA Approval Process, Let’s Fix It

Published October 22, 2013 by OSP

There is one certainty about the current regulatory process for drug approval in the United States and Europe: No one likes it.  Can this process be altered? Yes, but it will require a true reinvention of the regulatory drug-review process that addresses all of the flawed assumptions that exist with the current framework. One potential solution is adaptive licensing (also called “staggered approval” and “progressive licensing”), a novel approach that is currently being discussed by manufacturers, regulators, and other stakeholders.

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