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

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Characteristics of Clinical Studies Used for US Food and Drug Administration Approval of High-Risk Medical Device Supplements.US Food and Drug Administration Clearance of Moderate-Risk Otolaryngologic Devices via the 510(k) Process, 1997-2016.

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P2860

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

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2017 nî lūn-bûn

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Clinical Evidence Supporting U ...... ryngologic Devices, 2000-2014.

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Clinical Evidence Supporting U ...... ryngologic Devices, 2000-2014.

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Clinical Evidence Supporting U ...... ryngologic Devices, 2000-2014.

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P1476

Clinical Evidence Supporting U ...... ryngologic Devices, 2000-2014.

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Bo Wang

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Nicholas S Downing

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Stacey T Gray

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Vinay K Rathi

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P2860

Inclusion of comparative effectiveness data in high-risk cardiovascular device studies at the time of premarket approval.

Clinical trial evidence supporting FDA approval of novel therapeutic agents, 2005-2012.

Pivotal clinical trials of novel ophthalmic drugs and medical devices: retrospective observational study, 2002-2012

Postmarketing trials and pediatric device approvals.

Stenting versus aggressive medical therapy for intracranial arterial stenosis.

Participation of the elderly, women, and minorities in pivotal trials supporting 2011-2013 U.S. Food and Drug Administration approvals.

Using effectiveness and cost-effectiveness to make drug coverage decisions: a comparison of Britain, Australia, and Canada.

Strength of study evidence examined by the FDA in premarket approval of cardiovascular devices.

Physicians' Knowledge About FDA Approval Standards and Perceptions of the "Breakthrough Therapy" Designation.

Semper fidelis--consumer protection for patients with implanted medical devices.

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285-288

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scholarly article

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10.1177/0194599816684094

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156

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Joseph S. Ross

Aaron S Kesselheim

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2017-01-01T00:00:00Z

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28093943

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drug approval

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

about

P2860

P2860

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

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