Citations 7
Characteristics of Clinical Studies Used for US Food and Drug Administration Supplemental Indication Approvals of Drugs and Biologics, 2017 to 2019
Zhang, Audrey D. , Puthumana, Jeremy , Downing, Nicholas S., Shah, Nilay D. , Dhodapkar, Meera M. , Ross, Joseph S.
JAMA Network Open | June 10, 2021 | Volume: 4 | Issue: 6 | Pages: e2113224
Assessment of Clinical Trials Supporting US Food and Drug Administration Approval of Novel Therapeutic Agents, 1995-2017
Zhang, Audrey D. , Puthumana, Jeremy , Downing, Nicholas S., Shah, Nilay D. , Ross, Joseph S. , Ross, Joseph S , Krumholz, Harlan M.
JAMA Network Open | April 21, 2020 | Volume: 3 | Issue: 4 | Pages: e203284
New and incremental FDA black box warnings from 2008 to 2015
Solotke, Michael T. , Dhruva, Sanket S. , Downing, Nicholas S., Shah, Nilay D. , Ross, Joseph S. , Ross, Joseph S
Expert Opinion on Drug Safety | December 7, 2017 | Volume: 17 | Issue: 2 | Pages: 117-123
Characteristics of Novel Therapeutics and Postmarket Safety Events—Reply
Downing, Nicholas S., Shah, Nilay D. , Ross, Joseph S. , Ross, Joseph S
JAMA | October 3, 2017 | Volume: 318 | Issue: 11 | Pages: 1067
Postmarket Safety Events Among Novel Therapeutics Approved by the US Food and Drug Administration Between 2001 and 2010
Downing, Nicholas S., Shah, Nilay D. , Aminawung, Jenerius A. , Pease, Alison M., Zeitoun, Jean-David, Ross, Joseph S. , Zeitoun, Jean‐David , Krumholz, Harlan M. , Ross, Joseph S
JAMA | May 11, 2017 | Volume: 317 | Issue: 18 | Pages: 1854
Descriptions and Interpretations of the ACCORD-Lipid Trial in the News and Biomedical Literature
Downing, Nicholas S., Cheng, Theresa M., Shah, Nilay D. , Ross, Joseph S. , Cheng, Theresa, Krumholz, Harlan M. , Ross, Joseph S
JAMA Internal Medicine | May 6, 2014 | Volume: 174 | Issue: 7 | Pages: 1176
Clinical Trial Evidence Supporting FDA Approval of Novel Therapeutic Agents, 2005-2012
Downing, Nicholas S., Aminawung, Jenerius A. , Shah, Nilay D. , Ross, Joseph S. , Krumholz, Harlan M. , Ross, Joseph S
JAMA | January 21, 2014 | Volume: 311 | Issue: 4 | Pages: 368