Incentivizing Orphan Product Development: United States Food and Drug Administration Orphan Incentive Programs

Advances in Experimental Medicine and Biology - Rare Diseases Epidemiology: Update and Overview ◽

10.1007/978-3-319-67144-4_10 ◽

2017 ◽

pp. 183-196 ◽

Cited By ~ 2

Author(s):

Tran T. Le

Keyword(s):

United States ◽

Product Development ◽

Drug Administration ◽

Food And Drug Administration ◽

Incentive Programs ◽

United States Food ◽

States Food

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Developing Drugs for Prevention of Chemotherapy-Induced Nausea and Vomiting: Draft Guidance from the United States Food and Drug Administration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

Food And Drug Administration ◽

The United States ◽

Nausea And Vomiting ◽

Draft Guidance ◽

United States Food ◽

States Food

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Corrigendum to ‘Validation of high-sensitivity performance for a United States Food and Drug Administration cleared cardiac troponin I assay’ [Clin. Biochem. 56 (2018) 4–10]

Clinical Biochemistry ◽

10.1016/j.clinbiochem.2018.06.008 ◽

2018 ◽

Vol 58 ◽

pp. 132

Author(s):

Robert H. Christenson ◽

Kristin Mullins ◽

Show-Hong Duh

Keyword(s):

United States ◽

Drug Administration ◽

Cardiac Troponin ◽

Troponin I ◽

Food And Drug Administration ◽

High Sensitivity ◽

Cardiac Troponin I ◽

United States Food ◽

States Food ◽

Sensitivity Performance

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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 ◽

Food And Drug Administration ◽

The United States ◽

Glutathione Depletion ◽

United States Food ◽

States Food

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United States Food and Drug Administration approach to risk evaluation and risk management for foods

Regulatory Toxicology and Pharmacology ◽

10.1016/0273-2300(83)90040-5 ◽

1983 ◽

Vol 3 (2) ◽

pp. 152-157 ◽

Cited By ~ 1

Author(s):

Arthur Hull Hayes

Keyword(s):

United States ◽

Risk Management ◽

Drug Administration ◽

Risk Evaluation ◽

Food And Drug Administration ◽

United States Food ◽

States Food

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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 ◽

Food And Drug Administration ◽

The United States ◽

Drug Products ◽

United States Food ◽

States Food

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

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

10.3109/9780203026656-8 ◽

2004 ◽

pp. 57-97

Keyword(s):

United States ◽

Drug Administration ◽

Food And Drug Administration ◽

The United States ◽

Good Manufacturing Practice ◽

Active Pharmaceutical Ingredients ◽

Pharmaceutical Ingredients ◽

United States Food ◽

States Food

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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 ◽

Food And Drug Administration ◽

The United States ◽

Regulatory Aspects ◽

New Drug ◽

United States Food ◽

States Food

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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 ◽

Food And Drug Administration ◽

Implantable Collamer Lens ◽

United States Food ◽

States Food

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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 ◽

Food And Drug Administration ◽

The United States ◽

United States Food ◽

States Food

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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 ◽

Food And Drug Administration ◽

The United States ◽

Regulatory Science ◽

United States Food ◽

States Food

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