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Esketamine for Treatment-Resistant Depression - First FDA-Approved Antidepressant in a New Class

The New England journal of medicine, 2019-07, Vol.381 (1), p.1-4

2019

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Two metres or one: what is the evidence for physical distancing in covid-19?

BMJ (Online), 2020-08, Vol.370, p.m3223

2020

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Hy's law: predicting serious hepatotoxicity

Pharmacoepidemiology and drug safety, 2006-04, Vol.15 (4), p.241-243

Temple, Robert

2006

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Challenges of developing and conducting clinical trials in rare disorders

American journal of medical genetics. Part A, 2018-04, Vol.176 (4), p.773-783

2018

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Participation of Women in Clinical Trials Supporting FDA Approval of Cardiovascular Drugs

Journal of the American College of Cardiology, 2018-05, Vol.71 (18), p.1960-1969

2018

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The imperative of overcoming barriers to the conduct of large, simple trials

JAMA : the journal of the American Medical Association, 2014-04, Vol.311 (14), p.1397

2014

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Zolpidem and driving impairment--identifying persons at risk

The New England journal of medicine, 2013-08, Vol.369 (8), p.689-691

2013

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Farewell to our Wonderful Friend and Colleague, J. Richard (Dick) Crout (1929–2020)

Clinical pharmacology and therapeutics, 2021-06, Vol.109 (6), p.1384-1387

2021

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The US Food and Drug Administration's Perspective on the New Antipsychotic Pimavanserin

The journal of clinical psychiatry, 2017-06, Vol.78 (6), p.e668-e673

2017

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Classification of aerosol-generating procedures: a rapid systematic review

BMJ open respiratory research, 2020-10, Vol.7 (1), p.e000730

2020

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Independent data monitoring committees: Preparing a path for the future

The American heart journal, 2014-08, Vol.168 (2), p.135-141.e1

2014

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Placebo-controlled trials and active-control trials in the evaluation of new treatments. Part 1: ethical and scientific issues

Annals of internal medicine, 2000-09, Vol.133 (6), p.455

2000

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Use of US Food and Drug Administration Expedited Drug Development and Review Programs by Orphan and Nonorphan Novel Drugs Approved From 2008 to 2021

JAMA network open, 2022-11, Vol.5 (11), p.e2239336-e2239336

2022

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The Devil Is Always in the Details

JACC. Cardiovascular interventions, 2017-04, Vol.10 (7), p.667-671

2017

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BiDil for heart failure in black patients: The U.S. Food and Drug Administration perspective

Annals of internal medicine, 2007-01, Vol.146 (1), p.57

2007

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Long-term soft tissue outcomes for hydroxyapatite-coated bone-anchored hearing implant surgery

European archives of oto-rhino-laryngology, 2019-11, Vol.276 (11), p.3067-3072

2019

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New Era in Drug Interaction Evaluation: US Food and Drug Administration Update on CYP Enzymes, Transporters, and the Guidance Process

Journal of clinical pharmacology, 2008-06, Vol.48 (6), p.662-670

2008

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Osseointegrated Hearing Implant Surgery Using a Novel Hydroxyapatite-Coated Concave Abutment Design

Otolaryngology-head and neck surgery, 2014-12, Vol.151 (6), p.1014-1019

2014

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New FDA Regulation to Improve Safety Reporting in Clinical Trials

The New England journal of medicine, 2011-07, Vol.365 (1), p.3-5

2011

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Bleeding Academic Research Consortium consensus report: the Food and Drug Administration perspective

Circulation (New York, N.Y.), 2011-06, Vol.123 (23), p.2664-2665

2011

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Encouragement of subgroup assessment by the FDA

Pharmaceutical statistics : the journal of the pharmaceutical industry, 2021-09, Vol.20 (5), p.923-928

Temple, Robert

2021

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The US Food and Drug Administration's perspective on the new antidepressant vortioxetine

The journal of clinical psychiatry, 2015-01, Vol.76 (1), p.8-14

2015

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Vilazodone: clinical basis for the US Food and Drug Administration's approval of a new antidepressant

The journal of clinical psychiatry, 2011-09, Vol.72 (9), p.1166-1173

2011

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Cooperative Perception for 3D Object Detection in Driving Scenarios Using Infrastructure Sensors

IEEE transactions on intelligent transportation systems, 2022-03, Vol.23 (3), p.1852-1864

2022

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Summary of findings from the FDA regulatory science forum on measuring sexual dysfunction in depression trials

The journal of clinical psychiatry, 2015-08, Vol.76 (8), p.1050-1059

2015

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Esketamine for Treatment-Resistant Depression - First FDA-Approved Antidepressant in a New Class

Two metres or one: what is the evidence for physical distancing in covid-19?

Hy's law: predicting serious hepatotoxicity

Challenges of developing and conducting clinical trials in rare disorders

Participation of Women in Clinical Trials Supporting FDA Approval of Cardiovascular Drugs

The imperative of overcoming barriers to the conduct of large, simple trials

Zolpidem and driving impairment--identifying persons at risk

Farewell to our Wonderful Friend and Colleague, J. Richard (Dick) Crout (1929–2020)

The US Food and Drug Administration's Perspective on the New Antipsychotic Pimavanserin

Classification of aerosol-generating procedures: a rapid systematic review

Independent data monitoring committees: Preparing a path for the future

Placebo-controlled trials and active-control trials in the evaluation of new treatments. Part 1: ethical and scientific issues

Use of US Food and Drug Administration Expedited Drug Development and Review Programs by Orphan and Nonorphan Novel Drugs Approved From 2008 to 2021

The Devil Is Always in the Details

BiDil for heart failure in black patients: The U.S. Food and Drug Administration perspective

Long-term soft tissue outcomes for hydroxyapatite-coated bone-anchored hearing implant surgery

New Era in Drug Interaction Evaluation: US Food and Drug Administration Update on CYP Enzymes, Transporters, and the Guidance Process

Osseointegrated Hearing Implant Surgery Using a Novel Hydroxyapatite-Coated Concave Abutment Design

New FDA Regulation to Improve Safety Reporting in Clinical Trials

Bleeding Academic Research Consortium consensus report: the Food and Drug Administration perspective

Encouragement of subgroup assessment by the FDA

The US Food and Drug Administration's perspective on the new antidepressant vortioxetine

Vilazodone: clinical basis for the US Food and Drug Administration's approval of a new antidepressant

Cooperative Perception for 3D Object Detection in Driving Scenarios Using Infrastructure Sensors

Summary of findings from the FDA regulatory science forum on measuring sexual dysfunction in depression trials

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