FDA approval trends

Approvals per year across all application types.

FDA approvals by year, by type

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By drug type, last 10 years

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Expedited program designations, % of that year's approvals

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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.