Sage Journals: Discover world-class research

Retricted access

Research article

First published 2017-2

Clinical Evidence Supporting US Food and Drug Administration Premarket Approval of High-Risk Otolaryngologic Devices,2000-2014

Vinay K. Rathi, Bo Wang, Joseph S. Ross [...]

Otolaryngology–Head and Neck Surgery

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Research article

First published 2015-9

Postmarket Modifications of High-Risk Therapeutic Devices in Otolaryngology Cleared by the US Food and Drug Administration

Vinay K. Rathi, Joseph S. Ross, Andre M. Samuel [...]

Otolaryngology–Head and Neck Surgery

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Research article

First published 2018-6

The US Food and Drug Administration’s expedited approval programs: Addressing premarket flexibility with enhanced postmarket evidence generation

Joshua D Wallach, Joseph S Ross, Huseyin Naci

Clinical Trials

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Research article

First published 2019-11

Recalls and Premarket Review Systems for High-Risk Medical Devices in Japan

Motoko Nakayama, Shiro Tanaka, Shota Hamada [...]

Therapeutic Innovation & Regulatory Science

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Research article

First published 2026

Premarket and postmarket real-world evidence studies supporting U.S. Food and Drug Administration regulatory decision-making,2016–2024

Louis Y Li, Reshma Ramachandran, Joseph S Ross [...]

Clinical Trials

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Research article

First published 2002-12

Regulatory Aspects of Invasive Glucose Measurements

Steve Gutman, Patricia Bernhardt, Arleen Pinkos [...]

Diabetes Technology & Therapeutics

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Research article

First published 1987-4

Criteria for Approval of Controlled-Release Products

Paula Botstein

Therapeutic Innovation & Regulatory Science

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Research article

First published 2008-04

Supplemental Applications Proposing Labeling Changes for Approved Drugs,Biologics,and Medical Devices [excerpts]

Biotechnology Law Report

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Research article

First published 1978-12

Health Device Legislation: An Overview of the Law and Its Impact on Respiratory Care

M Lee Bancroft, John A Steen

Respiratory Care

Open access

Review article

First published 2020-4

New Medical Device and Therapeutic Approvals in Otolaryngology: State of the Art Review of 2019

Anais Rameau, Robert Stephen Hong, Hamid Djalilian [...]

OTO Open

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