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Accelerated approval (FDA)

Index Accelerated approval (FDA)

The United States Food and Drug Administration (FDA) initiated the FDA Accelerated Approval Program in 1992 to allow faster approval of drugs for serious conditions that fill an unmet medical need. [1]

5 relations: Fast track (FDA), Food and Drug Administration, Liberty Fund, Orphan drug, Surrogate endpoint.

Fast track (FDA)

Fast Track is a designation by the United States Food and Drug Administration (FDA) of an investigational drug for expedited review to facilitate development of drugs which treat a serious or life-threatening condition and fill an unmet medical need.

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Food and Drug Administration

The Food and Drug Administration (FDA or USFDA) is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments.

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Liberty Fund

Liberty Fund, Inc. is a nonprofit foundation headquartered in Indianapolis, Indiana which promulgates the libertarian views of its founder, Pierre F. Goodrich through publishing, conferences, and educational resources.

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Orphan drug

An orphan drug is a pharmaceutical agent that has been developed specifically to treat a rare medical condition, the condition itself being referred to as an orphan disease.

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Surrogate endpoint

In clinical trials, a surrogate endpoint (or marker) is a measure of effect of a specific treatment that may correlate with a real clinical endpoint but does not necessarily have a guaranteed relationship.

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Redirects here:

Accelerated Approval, Accelerated Approval (FDA), Accelerated approval, FDA Accelerated Approval, FDA Accelerated Approval Program.

References

[1] https://en.wikipedia.org/wiki/Accelerated_approval_(FDA)

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