Citations

Early experience with the FDA’s regulatory review of novel gene therapies

Puthumana, Jeremy , Egilman, Alexander C. , Naushad, Nida, Shah, Nilay D. , Shah, Nilay , Ramachandran, Reshma , Ross, Joseph S.

BMJ Evidence-Based Medicine | October 11, 2021 | Volume: 27 | Issue: 4 | Pages: 195-198

10.1136/bmjebm-2021-111720 | PMID 34635478

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

10.1001/jamanetworkopen.2021.13224 | PMID 34110392

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

10.1001/jamanetworkopen.2020.3284 | PMID 32315070