FDA approval trends
Approvals per year across all application types.
Expedited-designation approvals, raw counts
Each chart below shows raw approval counts for one FDA expedited program, starting the year that program was introduced.
Priority Review approvals by year
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*Priority Review was introduced by the Prescription Drug Fee Act of 1992.
Orphan approvals by year
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*FDA Orphan Designations were introduced by the Orphan Drug Act of 1983.
Accelerated approvals by year
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*The FDA Accelerated Approval Program was introduced in late 1992.
Fast Track approvals by year
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*Fast Track was introduced by the FDA Modernization Act of 1997.
Breakthrough approvals by year
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*Breakthrough Therapy Approval from the FDA was introduced in late 2013.