Yale Collaboration

Nov 13, 2024 | jamanetwork.com | Maryam Mooghali |Yale Collaboration |Sanket S Dhruva

Representativeness of Studies Required Under Medicare’s Coverage With Evidence Development Program Medicare beneficiaries are often inadequately represented in clinical studies supporting US Food and Drug Administration medical product approvals.1 In certain circumstances, the Centers for Medicare & Medicaid Services (CMS) covers items and services under the coverage with evidence development (CED) program, which requires patient enrollment in CMS-approved clinical studies to generate...

Aug 27, 2024 | jamanetwork.com | Maryam Mooghali |Yale Collaboration |Joshua D. Wallach |Joseph Ross

Key PointsQuestion  What are the premarket end points and postmarketing requirements for US Food and Drug Administration (FDA) breakthrough therapy–designated approvals? Findings  In this cross-sectional study of 157 original indications with breakthrough therapy designation, all accelerated approvals and 58% of traditional approvals were based on pivotal trials using surrogate markers as primary end points.

Aug 12, 2024 | jamanetwork.com | Kushal Kadakia |Joseph S. Ross |Yale Collaboration

At-Home Testing for Survivors of Sexual Assault—Empowerment or Exploitation?

May 1, 2024 | jamanetwork.com | Maryam Mooghali |Yale Collaboration |Ayman Mohammad |Joshua D. Wallach

Introduction The US Food and Drug Administration (FDA) launched the Real-Time Oncology Review (RTOR) program in 2018 to support earlier review of oncology therapeutics expected to be a substantial improvement over available therapy based on straightforward study designs and easily interpreted end points.1 Although RTOR applications have been associated with shorter median approval times,2,3 little is known about the evidence supporting RTOR indication approvals.

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.