Below are the most recent publications written about "Product Surveillance, Postmarketing" by people in Profiles.
-
Hwang TJ, Ross JS, Vokinger KN, Kesselheim AS. Association between FDA and EMA expedited approval programs and therapeutic value of new medicines: retrospective cohort study. BMJ. 2020 10 07; 371:m3434.
-
Rathi VK, Krumholz HM, Masoudi FA, Ross JS. Postmarket Clinical Evidence for High-Risk Therapeutic Medical Devices Receiving Food and Drug Administration Premarket Approval in 2010 and 2011. JAMA Netw Open. 2020 08 03; 3(8):e2014496.
-
Johnston JL, Dhruva SS, Ross JS, Rathi VK. Early experience with the FDA's Breakthrough Devices program. Nat Biotechnol. 2020 08; 38(8):933-938.
-
Burkhardt JK, Srinivasan V, Srivatsan A, Albuquerque F, Ducruet AF, Hendricks B, Gross BA, Jankowitz BT, Thomas AJ, Ogilvy CS, Maragkos GA, Enriquez-Marulanda A, Crowley RW, Levitt MR, Kim LJ, Griessenauer CJ, Schirmer CM, Dalal S, Piper K, Mokin M, Winkler EA, Abla AA, McDougall C, Birnbaum L, Mascitelli J, Litao M, Tanweer O, Riina H, Johnson J, Chen S, Kan P. Multicenter Postmarket Analysis of the Neuroform Atlas Stent for Stent-Assisted Coil Embolization of Intracranial Aneurysms. AJNR Am J Neuroradiol. 2020 06; 41(6):1037-1042.
-
Bhasale A, Mintzes B, Sarpatwari A. Communicating emerging risks of SGLT2 inhibitors-timeliness and transparency of medicine regulators. BMJ. 2020 04 29; 369:m1107.
-
Resnic FS, Majithia A, Dhruva SS, Ssemaganda H, Robbins S, Marinac-Dabic D, Hewitt K, Ohno-Machado L, Reynolds MR, Matheny ME. Active Surveillance of the Implantable Cardioverter-Defibrillator Registry for Defibrillator Lead Failures. Circ Cardiovasc Qual Outcomes. 2020 04; 13(4):e006105.
-
Dhruva SS, Parzynski CS, Gamble GM, Curtis JP, Desai NR, Yeh RW, Masoudi FA, Kuntz R, Shaw RE, Marinac-Dabic D, Sedrakyan A, Normand ST, Krumholz HM, Ross JS. Attribution of Adverse Events Following Coronary Stent Placement Identified Using Administrative Claims Data. J Am Heart Assoc. 2020 02 18; 9(4):e013606.
-
Li C, Deery SE, Eisenstein EL, Fong ZV, Dansey K, Davidson-Ray L, O'Neal B, Schermerhorn ML. Index and follow-up costs of endovascular abdominal aortic aneurysm repair from the Endurant Stent Graft System Post Approval Study (ENGAGE PAS). J Vasc Surg. 2020 09; 72(3):886-895.e1.
-
Varkevisser RRB, Swerdlow NJ, Verhagen HJM, Lyden SP, Schermerhorn ML. Similar 5-year outcomes between female and male patients undergoing elective endovascular abdominal aortic aneurysm repair with the Ovation stent graft. J Vasc Surg. 2020 07; 72(1):114-121.
-
Huang TY, Welch EC, Shinde MU, Platt RW, Filion KB, Azoulay L, Maro JC, Platt R, Toh S. Reproducing Protocol-Based Studies Using Parameterizable Tools-Comparison of Analytic Approaches Used by Two Medical Product Surveillance Networks. Clin Pharmacol Ther. 2020 04; 107(4):966-977.