Three-Year Results of Artisan/Verisyse Phakic Intraocular Lens Implantation: Results of the United States Food and Drug Administration Clinical Trial

Developing Drugs for Prevention of Chemotherapy-Induced Nausea and Vomiting: Draft Guidance from the United States Food and Drug Administration

Clinical Cancer Research ◽

10.1158/1078-0432.ccr-21-1941 ◽

2021 ◽

pp. clincanres.1941.2021

Author(s):

Erica Lyons ◽

Charles Line ◽

Jessica J Lee

Keyword(s):

United States ◽

Drug Administration ◽

The United States ◽

Nausea And Vomiting ◽

Draft Guidance ◽

United States Food ◽

Effects of hypoxia and glutathione depletion on hemoglobin- and myoglobin-mediated oxidative stress toward endothelium1The opinions and assertions contained herein are the scientific views of the authors and are not to be construed as policy of the United States Food and Drug Administration or the United States Army.1

Biochimica et Biophysica Acta (BBA) - Molecular Cell Research ◽

10.1016/s0167-4889(99)00163-9 ◽

2000 ◽

Vol 1495 (2) ◽

pp. 150-159 ◽

Cited By ~ 28

Author(s):

Felice D’Agnillo ◽

Francine Wood ◽

Carlos Porras ◽

Victor W. Macdonald ◽

Abdu I. Alayash

Keyword(s):

Oxidative Stress ◽

United States ◽

United States Army ◽

Drug Administration ◽

The United States ◽

Glutathione Depletion ◽

United States Food ◽

Harmonization by Doing Proposal for Global Clinical Trial Designs for Endovascular Devices for Treatment of Critical Limb Ischemia: The United States Food and Drug Administration Perspective

Circulation Journal ◽

10.1253/circj.cj-18-0817 ◽

2018 ◽

Vol 82 (12) ◽

pp. 3110-3111

Author(s):

Kenneth J. Cavanaugh Jr ◽

Donna C. Buckley ◽

Misti L. Malone

Keyword(s):

United States ◽

Clinical Trial ◽

Critical Limb Ischemia ◽

Limb Ischemia ◽

The United States ◽

Global Clinical Trial ◽

United States Food ◽

States Food ◽

Clinical Trial Designs ◽

Endovascular Devices

The Regulation of Drug Products by the United States Food and Drug Administration

The Textbook of Pharmaceutical Medicine ◽

10.1002/9780470987391.ch20 ◽

2007 ◽

pp. 565-601

Author(s):

Peter Barton Hutt

Keyword(s):

United States ◽

Drug Administration ◽

The United States ◽

Drug Products ◽

United States Food ◽

Phakic Intraocular Lens Implantation in United States Military Warfighters: A Retrospective Analysis of Early Clinical Outcomes of the Visian ICL

Journal of Refractive Surgery ◽

10.3928/1081597x-20110106-03 ◽

2011 ◽

Vol 27 (7) ◽

pp. 473-481 ◽

Cited By ~ 8

Author(s):

Gregory D. Parkhurst ◽

Maximilian Psolka ◽

Guy M. Kezirian

Keyword(s):

United States ◽

Retrospective Analysis ◽

Clinical Outcomes ◽

Intraocular Lens ◽

United States Military ◽

Intraocular Lens Implantation ◽

Phakic Intraocular Lens ◽

Lens Implantation ◽

Early Clinical Outcomes

GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers, (Volume 2 - Regulations, Standards, and Guidelines) ◽

The United States Food and Drug Administration and ICH Guidance for Industry Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients

10.3109/9780203026656-8 ◽

2004 ◽

pp. 57-97

Keyword(s):

United States ◽

Drug Administration ◽

The United States ◽

Good Manufacturing Practice ◽

Active Pharmaceutical Ingredients ◽

Pharmaceutical Ingredients ◽

United States Food ◽

Regulatory Aspects of Chemistry Manufacturing and Controls for Investigational New Drug Applications and Biologic License Applications to the United States Food and Drug Administration

Comprehensive Biotechnology ◽

10.1016/b978-0-444-64046-8.00178-6 ◽

2019 ◽

pp. 473-486

Author(s):

K. Lee

Keyword(s):

United States ◽

Drug Administration ◽

The United States ◽

Regulatory Aspects ◽

New Drug ◽

United States Food ◽

UNITED STATES FOOD AND DRUG ADMINISTRATION CLINICAL TRIAL OF THE IMPLANTABLE COLLAMER LENS (ICL) FOR MODERATE TO HIGH MYOPIA: THREE-YEAR FOLLOW-UP

Evidence-Based Eye Care ◽

10.1097/01.ieb.0000150394.99132.71 ◽

2005 ◽

Vol 6 (1) ◽

pp. 38-40

Author(s):

Eric Donnenfeld

Keyword(s):

United States ◽

Clinical Trial ◽

Drug Administration ◽

High Myopia ◽

Implantable Collamer Lens ◽

United States Food ◽

The United States Food and Drug Administration

Cobert's Manual of Drug Safety and Pharmacovigilance ◽

10.1142/9789813278851_0008 ◽

2019 ◽

pp. 59-77 ◽

Cited By ~ 1

Keyword(s):

United States ◽

Drug Administration ◽

The United States ◽

United States Food ◽

Regulatory science: a special update from the United States Food and Drug Administration

Toxicology Letters ◽

10.1016/s0378-4274(99)00152-6 ◽

2000 ◽

Vol 111 (3) ◽

pp. 199-202 ◽

Cited By ~ 19

Author(s):

Kuei-Meng Wu ◽

Joseph G. DeGeorge ◽

Aisar Atrakchi ◽

Estella Barry ◽

Anita Bigger ◽

...

Keyword(s):

United States ◽

Drug Administration ◽

The United States ◽

Regulatory Science ◽

United States Food ◽