Reshma Ramachandran

Mar 20, 2024 | jamanetwork.com | Sahil Agrawal |Joseph Ross |Yale Collaboration |Reshma Ramachandran

On January 17, 2024, the US Supreme Court heard oral arguments in 2 combined cases, Loper Bright Enterprises v Raimondo and Relentless, Inc v Department of Commerce, that will determine the fate of Chevron deference, a bedrock principle of administrative law that obligates courts to defer to an agency’s reasonable interpretations of ambiguous statutes.1 Although the US Supreme Court has not invoked Chevron in nearly a decade, lower courts regularly rely on Chevron deference.

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...

Sep 16, 2023 | mdpi.com | Jonathan Moon |Reshma Ramachandran |Yi Liang |Jan DuBien

1. IntroductionPoultry meat represented almost 40 percent of global meat production in 2020 [1]. Poultry is one of the main sources of animal protein due to its universal acceptability, high nutritional value, and health benefits [2]. The growth in global population has pressured the poultry industry to increase its production capacity [3,4,5]. Global meat production doubled from 1980 to 2004 and is projected to double again from 2000 to 2050 [6].

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.

Jun 12, 2023 | jamanetwork.com | James Johnston |Joseph S. Ross |Reshma Ramachandran

Approval of Drugs With Unmet Trial End Points—In Reply FDA Approval of Drugs Not Meeting Pivotal Trial Primary End Points James L. Johnston, MD; Joseph S. Ross, MD, MHS; Reshma Ramachandran, MD, MPP, MHS Approval of Drugs With Unmet Trial End Points Indranil Bhattacharya, PhD; Iraj Daizadeh, PhD; Andrew S.