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Concept
Fast Track Designation
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Summary
Fast Track Designation
is a process by the
U.S. Food and Drug Administration
(FDA) designed to expedite the review of drugs that treat
Serious Conditions
and fill an
Unmet Medical Need
. This designation aims to bring
Important new drugs
to
Patients more quickly
by facilitating more
Frequent interactions with the FDA
and allowing for a
Rolling review of the drug's application
.
Concepts
Drug Development
Regulatory Affairs
Clinical Trials
Unmet Medical Need
Expedited Drug Approval
Rolling Review
FDA Review Process
Serious Conditions
FDA Approval Process
Relevant Degrees
General and Professional Pharmacy 60%
Public and Professional Organization of Health 30%
Sectors of the Economy 10%
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