Longitudinal Patterns in Testosterone Prescribing After US FDA Safety Communication in 2014
Sankar A, Everhart A, Jena A, Jeffery M, Ross J, Shah N, Karaca-Mandic P. Longitudinal Patterns in Testosterone Prescribing After US FDA Safety Communication in 2014. The Joint Commission Journal On Quality And Patient Safety 2023, 49: 458-466. PMID: 37380503, DOI: 10.1016/j.jcjq.2023.05.003.Peer-Reviewed Original ResearchConceptsCoronary artery diseaseFDA safety communicationPhysician characteristicsLabel prescribingCare physiciansTestosterone prescribingService administrative claims dataNon-primary care physiciansCertain physician characteristicsDrug Administration (FDA) safety communicationPrimary care physiciansAdministrative claims dataCase mix indexTestosterone therapyArtery diseaseTestosterone prescriptionsPrescribing levelsMean agePrescription trendsTeaching hospitalClaims dataPrescription levelsMedicare feePrescribingUS FoodUS Food and Drug Administration regulatory reviewer disagreements and postmarket safety actions among new therapeutics
Eadie A, MacGregor A, Wallach J, Ross J, Herder M. US Food and Drug Administration regulatory reviewer disagreements and postmarket safety actions among new therapeutics. BMJ Evidence-Based Medicine 2023, 28: 151-156. PMID: 36944478, DOI: 10.1136/bmjebm-2022-112005.Peer-Reviewed Original ResearchConceptsNovel therapeuticsNew therapeuticsUS FoodReviewer disagreementTherapeutic approvalsFDA safety communicationCross-sectional studyBlack box warningPatient populationBox warningDrug AdministrationDrug approvalFDA reviewSafety actionsRegulatory approvalTherapeuticsFDAApprovalMarket approvalFDA reviewersReviewersInstances of disagreementReviewActionAdministration