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- FDA_Accelerated_Approval abstract "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. 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 endpoint, or something that is thought to predict clinical benefit. Surrogate endpoints typically require less time, and in the case of a cancer patient, it is much faster to measure a reduction in tumor size, for example, than overall patient survival. Drugs approved under the FDA Accelerated Approval Program still need to be tested in clinical trials using endpoints that demonstrate clinical benefit, and those trials are known as Phase 4 confirmatory trials. If the drug later proves unable to demonstrate clinical benefit to patients, the FDA may withdraw approval.".
- FDA_Accelerated_Approval wikiPageExternalLink DrugLag.html.
- FDA_Accelerated_Approval wikiPageID "40167858".
- FDA_Accelerated_Approval wikiPageRevisionID "570998074".
- FDA_Accelerated_Approval subject Category:Clinical_research.
- FDA_Accelerated_Approval subject Category:Food_and_Drug_Administration.
- FDA_Accelerated_Approval subject Category:Pharmaceutical_industry.
- FDA_Accelerated_Approval comment "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. Drug approval typically requires clinical trials with endpoints that demonstrate a clinical benefit, such as increased survival for cancer patients.".
- FDA_Accelerated_Approval label "FDA Accelerated Approval".
- FDA_Accelerated_Approval sameAs m.0wkp6l2.
- FDA_Accelerated_Approval sameAs Q17005771.
- FDA_Accelerated_Approval sameAs Q17005771.
- FDA_Accelerated_Approval wasDerivedFrom FDA_Accelerated_Approval?oldid=570998074.
- FDA_Accelerated_Approval isPrimaryTopicOf FDA_Accelerated_Approval.