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Research article

First published 2012-9

Concepts for the Risk-Based Regulation of Clinical Research on Medicines and Medical Devices

Markus Hartmann, Florence Hartmann-Vareilles

Therapeutic Innovation & Regulatory Science

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Review article

First published 2019

The Medical Device Regulation of the European Union Intensifies Focus on Clinical Benefits of Devices

Beata Wilkinson, Robert van Boxtel

Therapeutic Innovation & Regulatory Science

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Research article

First published 2012-10

Understanding Food and Drug Administration Regulatory Requirements for an Investigational Device Exemption for Sponsor-Investigators

M. E. Blair Holbein, Jelena Petrovic Berglund

Journal of Investigative Medicine

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Research article

First published 2015-10

The Food and Drug Administration and pragmatic clinical trials of marketed medical products

Monique L Anderson, Joseph Griffin, Sara F Goldkind [...]

Clinical Trials

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Research article

First published 2012-3

How safe are new medical devices?

Stephen J. Humphreys

Research Ethics

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Research article

First published 2023-11-1

Digitalizing the Supply Chain of Clinical Trials

Deborah Antonuccio, Lukas Buser, Joachim Ehrenthal [...]

Journal of Information Technology Teaching Cases

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Research article

First published 1989-10

The Nuclear Pharmacist in Industry

Raymond F. Schmelter, James F. Godat, Clyde N. Cole

Journal of Pharmacy Practice

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Brief report

First published 2016-1

Using a Handheld Device for Patient Data Collection: A Pilot for Medical Countermeasures Surveillance

Matthew F. Daley, Kristin Goddard, Melissa McClung [...]

Public Health Reports®

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Research article

First published 1987-1

Progress in Development and Application of the University of California at San Francisco/Storz Multichannel Cochlear Implant

M. M. Merzenich, D. K. Kessler, S. J. Rebscher [...]

Annals of Otology,Rhinology & Laryngology

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Review article

First published 2018-12

Establishing a Current Good Manufacturing Practice Facility for Biomaterials and Biomolecules in an Academic Medical Center

Alexandra J. Greenberg-Worisek, Bethany Kinseth Runge, Sarah A. Solyntjes [...]

Tissue Engineering Part B: Reviews

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