About: Accelerated approval (FDA)

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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 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.

Attributes	Values
rdfs:label	Accelerated approval (FDA) (en) Aprobación acelerada (es)
rdfs: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. 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 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. (en) El Programa de Aprobación Acelerada fue iniciada en 1922 por la Agencia de Medicamentos y Alimentación de Estados Unidos con el fin de permitir la rápida aprobación de medicamentos para condiciones de salubridad graves que aún no han sido cubiertas. La aprobación más rápida se basa en el uso de resultados sustitutivos. (es)
dcterms:subject	Pharmaceutical industry Food and Drug Administration American medical research
Wikipage page ID	40167858 (xsd:integer)
Wikipage revision ID	1124395644 (xsd:integer)
Link from a Wikipage to another Wikipage	Orphan drug Food and Drug Administration Fast track (FDA) Pharmaceutical industry Food and Drug Administration American medical research Phases of clinical research Library of Economics and Liberty Concise Encyclopedia of Economics Surrogate endpoints
Link from a Wikipage to an external page	http://www.econlib.org/library/Enc1/DrugLag.html
sameAs	Accelerated approval (FDA) Accelerated approval (FDA) Accelerated approval (FDA)
dbp:wikiPageUsesTemplate	dbt:Cite_encyclopedia dbt:OCLC dbt:Reflist
has 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. 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 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. (en) El Programa de Aprobación Acelerada fue iniciada en 1922 por la Agencia de Medicamentos y Alimentación de Estados Unidos con el fin de permitir la rápida aprobación de medicamentos para condiciones de salubridad graves que aún no han sido cubiertas. La aprobación más rápida se basa en el uso de resultados sustitutivos. La aprobación de fármacos requiere, normalmente, resultados de ensayos clínicos que demuestren un beneficio, tal como el aumento de la supervivencia para los pacientes con cáncer. Las drogas con la aprobación acelerada pueden ser inicialmente probadas en ensayos clínicos que utilicen un resultado sustitutivo, o algo que esté pensado para predecir un beneficio clínico.Generalmente, los resultados sustitutivos requieren menos tiempo, y en el caso de un paciente con cáncer, es más rápido medir una reducción en el tamaño del tumor, por ejemplo, que en la supervivencia global de pacientes. Los medicamentos aprobados en el marco del Programa de la Aprobación Acelerada FDA deben ser probados en ensayos clínicos y deben demostrar un beneficio clínico. Estos ensayos se conocen como la fase IV o de confirmación. Si luego el medicamento no demuestra un beneficio clínico para los pacientes, la FDA podrá retirar la autorización. (es)
prov:wasDerivedFrom	wikipedia-en:Accelerated_approval_(FDA)?oldid=1124395644&ns=0
page length (characters) of wiki page	2406 (xsd:nonNegativeInteger)
foaf:isPrimaryTopicOf	wikipedia-en:Accelerated_approval_(FDA)
is Link from a Wikipage to another Wikipage of	Capmatinib FDA Accelerated Approval Brexucabtagene autoleucel Deferiprone Antibody-drug conjugate Sacituzumab govitecan Clovis Oncology Enfortumab vedotin Golodirsen Zanubrutinib Trastuzumab deruxtecan Aducanumab Amicus Therapeutics Amikacin Accelerated Approval (FDA) Breakthrough therapy Osimertinib Fast track (FDA) Tazemetostat FDA Accelerated Approval Program dbr:Migalastat Olaratumab Selinexor Accelerated Approval Accelerated approval
is Wikipage redirect of	FDA Accelerated Approval Accelerated Approval (FDA) FDA Accelerated Approval Program Accelerated Approval Accelerated approval
is foaf:primaryTopic of	wikipedia-en:Accelerated_approval_(FDA)

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