Maryam Mooghali

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.

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.

Feb 15, 2024 | healthaffairs.org | Kushal Kadakia |Vinay K. Rathi |Sanket S Dhruva |Maryam Mooghali |Claudia See |Joseph Ross | +1 more

The Food and Drug Administration (FDA) issues recalls for thousands of medical devices yearly due to safety issues. In January 2024, the Government Accountability Office (GAO) formally accepted a request from Congress, initiated by Senators Durbin (D-IL) and Blumenthal (D-CT), to review FDA’s oversight of device recalls in the wake of the far-reaching and ongoing recall initiated by Philips Respironics, which affected 15 million devices.

May 15, 2023 | jamanetwork.com | Maryam Mooghali |Yale Collaboration |Joseph S. Ross |Kushal Kadakia

Availability of Unique Device Identifiers for Class I Medical Device Recalls From 2018 to 2022 For medical devices, the US Food and Drug Administration (FDA) designates the highest severity recalls as Class I, indicating a reasonable likelihood of serious adverse events or death occurring with use.1 For example, HeartWare Ventricular Assist Device System (Medtronic), which provides circulatory support for end-stage heart failure, was recalled multiple times between 2013 and 2022 for risks...