Meera Dhodapkar

Feb 12, 2024 | jamanetwork.com | Guneet Janda |Joshua D. Wallach |Joseph S. Ross |Meera Dhodapkar

Hypothetical Assessments of Trial Emulations—Reply Feasibility of Emulating Trials Supporting Approvals of Drugs and Biologics Guneet S. Janda, BS; Joshua D. Wallach, PhD, MS; Meera M. Dhodapkar, BA; Reshma Ramachandran, MD, MPP, MHS; Joseph S. Ross, MD, MHS Hypothetical Assessments of Trial Emulations Sebastian Schneeweiss, MD, ScD; Shirley V.

Oct 2, 2023 | jamanetwork.com | Guneet Janda |Joshua D. Wallach |Meera Dhodapkar |Reshma Ramachandran

Feasibility of Emulating Clinical Trials Supporting US FDA Supplemental Indication Approvals of Drugs and Biologics The US Food and Drug Administration (FDA) has developed a framework to use data gathered outside of clinical trials (eg, electronic health record [EHR] and insurance claims data) for evaluations of medical product safety and effectiveness.1 These methods, typically characterized as target trial emulations,2,3 are expected to be most useful for evaluating new clinical indications...

Jun 26, 2023 | jamanetwork.com | Meera Dhodapkar |Joseph S. Ross |Yale Collaboration |Reshma Ramachandran

Introduction In October 2022, the US Food and Drug Administration (FDA) announced the Split Real-Time Application Review (STAR) pilot program under the Prescription Drug User Fee Authorization Act VII.1 Like its predecessor, the Real-Time Oncology Review (RTOR) program for oncology drugs, STAR is designed to shorten regulatory review of supplemental new indication approvals of drugs and biologics that treat serious conditions with an unmet need.