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GLOSSARY

Fast Track (FDA Designation)

DEFINITION

If a drug has been given a fast track FDA designation, a research project is given access to a wide variety of resources that are designed to expedite the research and review process. If a project shows preliminary clinical evidence that a drug may be able to fill a significant unmet need, or that it is significantly better than currently accepted treatment options, then the FDA may give a drug a fast track designation. The goal of this designation is to help medications get to the open market faster, giving patients access to new diagnostic and treatment options that may significantly improve their prognoses. Companies are able to apply for Fast Track designation at any time, and the goal is to get applications through the FDA in under 180 days.

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