2019
Medicare Prescription Drug Plan Formulary Restrictions After Postmarket FDA Black Box Warnings.
Solotke MT, Ross JS, Shah ND, Karaca-Mandic P, Dhruva SS. Medicare Prescription Drug Plan Formulary Restrictions After Postmarket FDA Black Box Warnings. Journal Of Managed Care & Specialty Pharmacy 2019, 25: 1201-1217. PMID: 31663461, PMCID: PMC10397710, DOI: 10.18553/jmcp.2019.25.11.1201.Peer-Reviewed Original ResearchConceptsBlack box warningFDA black box warningBox warningFormulary restrictionsFormulary coverageMean percentageNew black box warningsMain outcome measuresPrecision Health EconomicsNational InstituteOutcomes Research InstituteBlue Cross Blue Shield AssociationHealth care qualityCohort studyBoxed warningUnsafe medicationsDrug therapyStep therapy requirementsMayo ClinicFormulary changeOutcome measuresBlue Shield AssociationJohn Arnold FoundationDrug AdministrationFormulary management
2017
Blueprint for Transparency at the U.S. Food and Drug Administration: Recommendations to Advance the Development of Safe and Effective Medical Products
Sharfstein J, Miller J, Davis A, Ross J, McCarthy M, Smith B, Chaudhry A, Alexander G, Kesselheim A. Blueprint for Transparency at the U.S. Food and Drug Administration: Recommendations to Advance the Development of Safe and Effective Medical Products. The Journal Of Law, Medicine & Ethics 2017, 45: 7-23. DOI: 10.1177/1073110517750615.Commentaries, Editorials and LettersYale Law SchoolEffective medical productsSuch medical productsMedical productsJohn Arnold FoundationLaw schoolsCongressional authorizationDevelopment of SafeYale Medical SchoolFDA practiceCongressional actionRegulatory statusRegulatory processesTransparencyPolicy constraintsJohns Hopkins Bloomberg SchoolPractical recommendationsPublicPublic healthTask ForceSpecific recommendationsRecommendationsPracticeBlueprintAuthorization