2023
US 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
2022
Public Misinformation and Science Communication in Times of Public Health Crises
Vera MA, El-Khoury JM, Thorp H, Tofel RJ, Ross JS, Mandavilli A, Topol E. Public Misinformation and Science Communication in Times of Public Health Crises. Clinical Chemistry 2022, 68: 1008-1014. PMID: 35675305, DOI: 10.1093/clinchem/hvac088.Commentaries, Editorials and Letters
2019
Communicating, and Justifying, Nonefficacy Benefits for New Drugs Approved on the Basis of Noninferiority Trials
Ross JS, Wee CC. Communicating, and Justifying, Nonefficacy Benefits for New Drugs Approved on the Basis of Noninferiority Trials. JAMA Internal Medicine 2019, 179: 721-722. PMID: 30830205, DOI: 10.1001/jamainternmed.2018.8019.Commentaries, Editorials and Letters
2016
Making Electronic Health Records Work Better for Patient Care
Ross JS. Making Electronic Health Records Work Better for Patient Care. JAMA Internal Medicine 2016, 176: 560. PMID: 26974253, DOI: 10.1001/jamainternmed.2016.0219.Commentaries, Editorials and Letters
2015
Regulatory anticipation of postmarket safety problems for novel medicines approved by the EMA between 2001 and 2010: a cross‐sectional study
Zeitoun JD, Lefèvre JH, Downing NS, Bergeron H, Ross JS. Regulatory anticipation of postmarket safety problems for novel medicines approved by the EMA between 2001 and 2010: a cross‐sectional study. Pharmacoepidemiology And Drug Safety 2015, 25: 687-694. PMID: 26554874, DOI: 10.1002/pds.3910.Peer-Reviewed Original ResearchConceptsDear Healthcare Professional CommunicationsEuropean Medicines AgencySafety eventsSafety concernsHealthcare Professional CommunicationsNovel medicinesCentralized authorization procedureEMA websitePostmarket studiesRegulatory reviewPostmarket periodMedicines AgencyWithdrawalSafety communicationMedicineSafety evaluationReview