Clinical Evidence Supporting US Food and Drug Administration Approval of Otolaryngologic Prescription Drug Indications, 2005‐2014
Rathi VK, Wang B, Ross JS, Downing NS, Kesselheim AS, Gray ST. Clinical Evidence Supporting US Food and Drug Administration Approval of Otolaryngologic Prescription Drug Indications, 2005‐2014. Otolaryngology 2017, 156: 683-692. PMID: 28116974, DOI: 10.1177/0194599816689666.Peer-Reviewed Original ResearchConceptsPivotal studiesOriginal indicationPrimary endpointClinical evidenceDrug indicationsSupplemental indicationsUS FoodFDA approvalAvailable FDA documentsDouble-blinded studyDrug Administration approvalInformed treatment decisionsPivotal clinical studiesPremarket evidenceOtolaryngologic diseaseMedian enrollmentSurrogate markerAdministration approvalClinical studiesTreatment decisionsMost indicationsDrug AdministrationInitial approvalMultidisciplinary teamPrescription drugs