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Articles (1821)

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1-10 of 1821 results for US Food and Drug Administration approval

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Select article: The US Food and Drug Administration’s expedited approval programs: Evidentiary standards,regulatory trade-offs,and potential improvements

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Research article

First published 2018-6

The US Food and Drug Administration’s expedited approval programs: Evidentiary standards,regulatory trade-offs,and potential improvements

Joshua D Wallach, Joseph S Ross, Huseyin Naci

Clinical Trials

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

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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

Select article: Clinical Development of Biologics Approved by the US Food and Drug Administration,2003-2016

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Research article

First published 2019-11

Clinical Development of Biologics Approved by the US Food and Drug Administration,2003-2016

G. Caleb Alexander, Ken Ogasawara, Dana Wiegand [...]

Therapeutic Innovation & Regulatory Science

Select article: Pivotal trial characteristics and types of endpoints used to support Food and Drug Administration rare disease drug approvals between 2013 and 2022

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Research article

First published 2025-6

Pivotal trial characteristics and types of endpoints used to support Food and Drug Administration rare disease drug approvals between 2013 and 2022

Kyungwan Hong, Bridget Nugent, Abbas Bandukwala [...]

Clinical Trials

Select article: Clinical Evidence Supporting US Food and Drug Administration Approval of Otolaryngologic Prescription Drug Indications,2005-2014

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Research article

First published 2017-4

Clinical Evidence Supporting US Food and Drug Administration Approval of Otolaryngologic Prescription Drug Indications,2005-2014

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

Otolaryngology–Head and Neck Surgery

Select article: Ethical considerations in design of a study to evaluate a US Food and Drug Administration–approved indication: Antivenom versus placebo for copperhead envenomation

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Research article

First published 2014-10

Ethical considerations in design of a study to evaluate a US Food and Drug Administration–approved indication: Antivenom versus placebo for copperhead envenomation

Charles J Gerardo, Eric J Lavonas, Ross E McKinney

Clinical Trials

Select article: Evaluation of a Non-Food and Drug Administration-Approved Use of Cimetidine: Treatment of Pruritus Resulting from Epidural Morphine Analgesia

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Review article

First published 1991-7

Evaluation of a Non-Food and Drug Administration-Approved Use of Cimetidine: Treatment of Pruritus Resulting from Epidural Morphine Analgesia

Dennis W. Raisch, Alan D. Barreuther, Robert C. Osborne

Annals of Pharmacotherapy

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

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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

Select article: Recalls of Moderate- and High-Risk Otolaryngologic Devices Approved by the US Food and Drug Administration,2003-2019

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Research article

First published 2022-11

Recalls of Moderate- and High-Risk Otolaryngologic Devices Approved by the US Food and Drug Administration,2003-2019

Ish A. Talati, Keon M. Parsa, William Z. Gao

Otolaryngology–Head and Neck Surgery

Select article: Device Safety Implications of the Clinical Data Leading to US Food and Drug Administration Approval of Soft-Tissue Fillers

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Correction

First published 2017-09

Device Safety Implications of the Clinical Data Leading to US Food and Drug Administration Approval of Soft-Tissue Fillers

Mary E. Lohman, Comeron W. Ghobadi, Shuai Xu

Facial Plastic Surgery & Aesthetic Medicine

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