What are the Food and Drug Administration (FDA) requirements for identifying drug interactions when a drug is being developed for marketing in the United States?

Journal of Clinical Psychopharmacology ◽

10.1097/00004714-199406000-00021 ◽

1994 ◽

Vol 14 (3) ◽

pp. 220

Author(s):

Richard I. Shader

Keyword(s):

United States ◽

Drug Interactions ◽

Drug Administration ◽

Food And Drug Administration ◽

The United States

Download Full-text

Developing Drugs for Prevention of Chemotherapy-Induced Nausea and Vomiting: Draft Guidance from the United States Food and Drug Administration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Draft Guidance ◽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

Download Full-text

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 ◽

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 ◽

Download Full-text

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 ◽

Download Full-text

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 ◽

Download Full-text

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 ◽

Download Full-text

The United States Food and Drug Administration

Cobert's Manual of Drug Safety and Pharmacovigilance ◽

10.1142/9789813278851_0008 ◽

2019 ◽

pp. 59-77 ◽

Keyword(s):

United States ◽

Drug Administration ◽

Food And Drug Administration ◽

The United States ◽

United States Food ◽

Download Full-text

Regulatory Perspectives: One Academic Viewpoint From the United States

International Psychogeriatrics ◽

10.1017/s1041610203009335 ◽

2003 ◽

Vol 15 (S1) ◽

pp. 277-281

Author(s):

Peter Whitehouse

Keyword(s):

United States ◽

Cognitive Impairment ◽

Vascular Dementia ◽

Drug Administration ◽

Food And Drug Administration ◽

The United States ◽

New Drugs ◽

Vascular Pathology ◽

Vascular Burden ◽

The development of new drugs to treat vascular dementia and other conditions in which cognitive impairment is due at least in part to vascular pathology will require future interaction among academic, industry, and government regulatory clinicians and scientists. This article offers the author's perspective on the positive involvement of the Food and Drug Administration in development of conceptual frameworks and practical approaches to treatment of conditions characterized by vascular burden of the brain.

Download Full-text

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 ◽

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 ◽

Download Full-text

Prognostic Implication of the United States Food and Drug Administration-defined BCG-unresponsive Disease

European Urology ◽

10.1016/j.eururo.2018.09.028 ◽

2019 ◽

Vol 75 (1) ◽

pp. 8-10 ◽

Author(s):

Roger Li ◽

William B. Tabayoyong ◽

Charles C. Guo ◽

Graciela M. Nogueras González ◽

Neema Navai ◽

...

Keyword(s):

United States ◽

Drug Administration ◽

Food And Drug Administration ◽

The United States ◽

Prognostic Implication ◽

United States Food ◽

Download Full-text

Nonclinical Development of Radiopharmaceuticals: Regulatory Considerations for the United States Food and Drug Administration

From Morphological Imaging to Molecular Targeting ◽

10.1007/978-3-662-07310-0_8 ◽

2004 ◽

pp. 151-165

Author(s):

S. Wilson

Keyword(s):

United States ◽

Drug Administration ◽

Food And Drug Administration ◽

The United States ◽

United States Food ◽

Download Full-text