Primary human papillomavirus screening for cervical cancer in the United States-US Food and Drug Administration approval, clinical trials, and where we are today

2014 ◽  
Vol 122 (10) ◽  
pp. 720-729 ◽  
Author(s):  
Ritu Nayar ◽  
Robert A. Goulart ◽  
Patricia G. Tiscornia-Wasserman ◽  
Diane Davis Davey
Keyword(s):  
United States ◽  
Cervical Cancer ◽  
Clinical Trials ◽  
Human Papillomavirus ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
The United States

scholarly journals The United States Food and Drug Administration and Noninferiority Margins in Clinical Trials of Antimicrobial Agents

2002 ◽  
Vol 34 (6) ◽  
pp. 879-881 ◽  
Author(s):  
John H. Powers ◽  
David B. Ross ◽  
Erica Brittain ◽  
Renata Albrecht ◽  
Mark J. Goldberger
Keyword(s):  
United States ◽  
Clinical Trials ◽  
Drug Administration ◽  
Antimicrobial Agents ◽  
Food And Drug Administration ◽  
The United States ◽  
United States Food ◽  
States Food

scholarly journals Paediatric cardiovascular clinical trials: an analysis of ClinicalTrials.gov and the Food and Drug Administration Pediatric Drug Labeling Database

2015 ◽  
Vol 25 (S2) ◽  
pp. 172-180 ◽  
Author(s):  
Kevin D. Hill ◽  
Heather T. Henderson ◽  
Christoph P. Hornik ◽  
Jennifer S. Li
Keyword(s):  
United States ◽  
Clinical Trials ◽  
Optimal Design ◽  
Drug Administration ◽  
United States Of America ◽  
Capital Investment ◽  
Food And Drug Administration ◽  
The United States ◽  
Pediatric Drug ◽  
The Impact

AbstractRecent regulatory initiatives in the United States of America and Europe have transformed the paediatric clinical trials landscape by significantly increasing capital investment and paediatric trial volume. The purpose of this manuscript was to review the impact of these initiatives on the paediatric cardiovascular trials landscape when compared with other paediatric sub-specialties. We also evaluate factors that may have contributed to the success or failure of recent major paediatric cardiovascular trials so as to inform the optimal design and conduct of future trials in the field.

Regulatory Perspectives: One Academic Viewpoint From the United States

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 Brain

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.

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