2020
Confidentiality Orders and Public Interest in Drug and Medical Device Litigation
Egilman AC, Kesselheim AS, Krumholz HM, Ross JS, Kim J, Kapczynski A. Confidentiality Orders and Public Interest in Drug and Medical Device Litigation. JAMA Internal Medicine 2020, 180: 292-299. PMID: 31657836, DOI: 10.1001/jamainternmed.2019.5161.Commentaries, Editorials and LettersConceptsLegal practicePublic interestMedical device litigationImportant public health informationLegal standardsMedical device manufacturersLitigationSpecial communicationCourtObscure patternsCompany marketingMedical expertsRulesPublic health informationDevice manufacturersPublic healthSuccessful effortsLitigantsPracticePlaintiffsLawsuitsCertain typesInterestAccessDrug Administration
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