Accelerated approval (FDA)
id:
accelerated-approval-fda-193-2084273
title:
Accelerated approval (FDA)
text:
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. The faster approval relies on use of surrogate endpoints. Drug approval typically requires clinical trials with endpoints that demonstrate a clinical benefit, such as increased survival for cancer patients. Drugs with accelerated approval can initially be tested in clinical trials that use a surrogate
brand slug:
wiki
category slug:
encyclopedia
description:
original url:
https://en.wikipedia.org/wiki/Accelerated_approval_(FDA)
date created:
date modified:
2024-02-28T17:52:31Z
main entity:
{"identifier":"Q17005771","url":"https://www.wikidata.org/entity/Q17005771"}
image:
fields total:
13
integrity:
13