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dc.contributor.authorKuzucan, Aida
dc.contributor.authorPowers, John H
dc.contributor.authorDoshi, Peter
dc.date.accessioned2020-12-08T17:49:28Z
dc.date.available2020-12-08T17:49:28Z
dc.identifier.urihttp://hdl.handle.net/10713/14208
dc.description.abstractApproval by the US Food and Drug Administration (FDA) of a drug for a given indication is thought to reassure clinicians, other health care providers, and patients that substantial evidence of effectiveness exists for specific indicated populations (patients and diseases). This study examines whether FDA approval of certain antibiotics should be so reassuring for all patient populations identified in the FDA-approved labels. Specifically, this study compared patient populations covered by FDA-approved labels for 21 novel antibiotics approved between 1999 and 2018 to the patient exclusion and inclusion criteria of pivotal trials that supported those approvals. We found that every FDA-approved label for these antibiotics included at least one identifiable patient population that was explicitly excluded from enrolling in the supporting pivotal trials. Two antibiotics, bedaquiline and ceftazidime-avibactam, were approved for use in populations that were fully excluded from enrolling in registration trials.en_US
dc.description.urihttps://doi.org/10.1016/j.mayocp.2020.07.023en_US
dc.language.isoenen_US
dc.publisherElsevier Ltd.en_US
dc.relation.ispartofMayo Clinic Proceedingsen_US
dc.rightsCopyright © 2020 Mayo Foundation for Medical Education and Research. Published by Elsevier Inc. All rights reserved.en_US
dc.subjectFDAen_US
dc.subjectpatient populationsen_US
dc.subject.lcshUnited States. Food and Drug Administrationen_US
dc.subject.meshAnti-Bacterial Agentsen_US
dc.subject.meshClinical Trials as Topicen_US
dc.subject.meshDrug Approvalen_US
dc.titleAntibiotics Approved for Marketing in Populations Specifically Excluded From Premarketing Trials, 1999-2018en_US
dc.typeArticleen_US
dc.identifier.doi10.1016/j.mayocp.2020.07.023
dc.identifier.pmid33276841
dc.source.volume95
dc.source.issue12
dc.source.beginpage2699
dc.source.endpage2703
dc.source.countryEngland


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