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.

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 Outpatient Fluoroquinolone Prescription Fills in the United States, 2014-2020: Assessing the Impact of Food and Drug Administration Safety Warnings

2021 ◽  
Author(s):  
Deanna J. Buehrle ◽  
Marilyn M. Wagener ◽  
Cornelius J. Clancy
Keyword(s):  
United States ◽  
Drug Administration ◽  
Nurse Practitioners ◽  
Food And Drug Administration ◽  
Interrupted Time Series ◽  
The United States ◽  
Baseline Period ◽  
Interrupted Time Series Analysis ◽  
Prescription Audit ◽  
The Impact

Background: The impact of United States (US) Food and Drug Administration (FDA) safety warnings on outpatient fluoroquinolone use is unclear. Methods: Annual changes in outpatient ciprofloxacin, levofloxacin and moxifloxacin prescription fills (IQVIA National Prescription Audit databases) were assessed using a regression model. Monthly fills during baseline (August 2014–April 2016), first (May 2016–June 2018), and second FDA warning periods (July 2018–February 2020) were compared by interrupted time series analysis. Results: From 2015 through 2019, total fluoroquinolone fills decreased from 35,616,786 (111.1/1000 persons) to 21,100,050 (64.3/1000 persons) annually (10.8% annually (P=0.001)). Ciprofloxacin, levofloxacin, and moxifloxacin fills decreased annually by 10.4% (P=0.001), 11.2% (P<0.001), and 17.7% (P=0.008), respectively. During the baseline period, there was no significant change in monthly fluoroquinolone fills. In May 2016 and during the first warning period, monthly fluoroquinolone fills decreased significantly (P-values<0.001); the trend of decreased fills was significantly greater than that of the baseline period (P=0.02). There was no change in fluoroquinolone fills in July 2018. Monthly fills decreased significantly throughout the second warning period (P<0.001), but the trend did not differ from that of the first warning period. Trends for ciprofloxacin, the most commonly prescribed fluoroquinolone, were similar to those for the class. Fills of prescriptions by infectious diseases specialists (P<0.005) and nurse practitioners (P=0.04) significantly increased during the study. Conclusions: US outpatient fluoroquinolone prescription fills significantly decreased from August 2014-February 2020, most strongly in association with May 2016 FDA warnings. FDA safety warnings are useful tools for leveraging outpatient antimicrobial stewardship.

Tartrazine Revisited

1975 ◽  
Vol 9 (4) ◽  
pp. 198-203 ◽  
Author(s):  
Monte S. Cohon
Keyword(s):  
United States ◽  
Drug Administration ◽  
United States Of America ◽  
Food And Drug Administration ◽  
Clinical Manifestations ◽  
The United States ◽  
Allergic Reactions ◽  
Pharmaceutical Manufacturers

A compilation of tartrazine (FD and C No. 5) containing drugs from major pharmaceutical manufacturers in the United States of America appears. Characteristics of tartrazine, spectrum of its use, incidence of allergic reactions and relationship with other food and drug dyes are discussed, as are the clinical manifestations of such reactions. The importance of coercive tartrazine disclosure, as well as the disclosure of other excipients and additives by the Food and Drug Administration is emphasized.

Pentecostalism and African diaspora : a case study of the Redeemed Christian Church of God (RCCG), in North America

2020 ◽  
Vol 1 (2) ◽  
pp. 77-92
Author(s):  
Rotimi Williams Omotoye
Keyword(s):  
United States ◽  
North America ◽  
United States Of America ◽  
The United States ◽  
Church Of God ◽  
Sources Of Information ◽  
Christian Church ◽  
Secondary Sources ◽  
The Impact ◽  
The Church

Pentecostalism as a new wave of Christianity became more pronounced in 1970's and beyond in Nigeria. Since then scholars of Religion, History, Sociology and Political Science have shown keen interest in the study of the Churches known as Pentecostals because of the impact they have made on the society. The Redeemed Christian Church of God (RCCG) was established by Pastor Josiah Akindayomi in Lagos,Nigeria in 1952. After his demise, he was succeeded by Pastor Adeboye Adejare Enock. The problem of study of this research was an examination of the expansion of the Redeemed Christian Church of God to North America, Caribbean and Canada. The missionary activities of the church could be regarded as a reversed mission in the propagation of Christianity by Africans in the Diaspora. The methodology adopted was historical. The primary and secondary sources of information were also germane in the research. The findings of the research indicated that the Redeemed Christian Church of God was founded in North America by Immigrants from Nigeria. Pastor Adeboye Enock Adejare had much influence on the Church within and outside the country because of his charisma. The Church has become a place of refuge for many immigrants. They are also contributing to the economy of the United States of America. However, the members of the Church were faced with some challenges, such as security scrutiny by the security agencies. In conclusion, the RCCGNA was a denomination that had been accepted and embraced by Nigerians and African immigrants in the United States of America.

Didactic education in paediatric cardiology during the COVID-19 pandemic: a national fellow survey

2020 ◽  
pp. 1-4
Author(s):  
Madhusudan Ganigara ◽  
Chetan Sharma ◽  
Fernando Molina Berganza ◽  
Krittika Joshi ◽  
Andrew D. Blaufox ◽  
...  
Keyword(s):  
United States ◽  
Online Learning ◽  
United States Of America ◽  
Formal Education ◽  
Medical Training ◽  
Nationwide Survey ◽  
The United States ◽  
Negative Consequences ◽  
Paediatric Cardiology ◽  
The Impact

Abstract The coronavirus disease 2019 (COVID-19) pandemic has had a profound impact on medical educational curricula. We aimed to examine the impact of these unprecedented changes on the formal education of paediatric cardiology fellows through a nationwide survey. A REDCap™-based voluntary anonymous survey was sent to all current paediatric cardiology fellows in the United States of America in May, 2020. Of 143 respondents, 121 were categorical fellows, representing over one-fourth of all categorical paediatric cardiology fellows in the United States of America. Nearly all (140/143, 97.9%) respondents utilised online learning during the pandemic, with 134 (93.7%) reporting an increase in use compared to pre-pandemic. The percentage of respondents reporting curriculum supplementation with outside lectures increased from 11.9 to 88.8% during the pandemic. Respondents considered online learning to be “equally or more effective” than in-person lectures in convenience (133/142, 93.7%), improving fellow attendance (132/142, 93.0%), improving non-fellow attendance (126/143, 88.1%), and meeting individual learning needs (101/143, 70.6%). The pandemic positively affected the lecture curriculum of 83 respondents (58.0%), with 35 (24.5%) reporting no change and 25 (17.5%) reporting a negative effect. A positive effect was most noted by those whose programmes utilised supplemental outside lectures (62.2 versus 25.0%, p = 0.004) and those whose lecture frequency did not decrease (65.1 versus 5.9%, p < 0.001). Restrictions imposed by the COVID-19 pandemic have greatly increased utilisation of online learning platforms by medical training programmes. This survey reveals that an online lecture curriculum, despite inherent obstacles, offers advantages that may mitigate some negative consequences of the pandemic on fellowship education.

scholarly journals Do Environmental Stringency Policies and Human Development Reduce CO2 Emissions? Evidence from G7 and BRICS Economies

2021 ◽  
Vol 18 (13) ◽  
pp. 6727
Author(s):  
Funda Hatice Sezgin ◽  
Yilmaz Bayar ◽  
Laura Herta ◽  
Marius Dan Gavriletea
Keyword(s):  
United States ◽  
United Kingdom ◽  
Human Development ◽  
Co2 Emissions ◽  
United States Of America ◽  
The United States ◽  
Cointegration Analysis ◽  
Causality Analysis ◽  
The United Kingdom ◽  
The Impact

This study explores the impact of environmental policies and human development on the CO2 emissions for the period of 1995–2015 in the Group of Seven and BRICS economies in the long run through panel cointegration and causality tests. The causality analysis revealed a bilateral causality between environmental stringency policies and CO2 emissions for Germany, Japan, the United Kingdom, and the United States of America, and a unilateral causality from CO2 emissions to the environmental stringency policies for Canada, China, and France. On the other hand, the analysis showed a bilateral causality between human development and CO2 emissions for Germany, Japan, the United Kingdom, and the United States of America, and unilateral causality from CO2 emissions to human development in Brazil, Canada, China, and France. Furthermore, the cointegration analysis indicated that both environmental stringency policies and human development had a decreasing impact on the CO2 emissions.

The Dispensatory of the United States of America

PEDIATRICS ◽  
1948 ◽  
Vol 1 (6) ◽  
pp. 846-846
Keyword(s):  
United States ◽  
Drug Administration ◽  
United States Of America ◽  
Editorial Policy ◽  
The United States ◽  
Trade Mark ◽  
British Pharmacopoeia ◽  
Therapeutic Uses ◽  
Trade Name ◽  
New Feature

This edition is based on the U. S. P. XIII, N.F. VIII, N.N.R., 1947, and the British Pharmacopoeia, 1932, and its addenda. The significant change in editorial policy is the enlargement of that portion of each monograph devoted to a discussion of therapeutic uses and dosage of drugs, and an increased emphasis placed upon precautions to be observed during drug administration. Another new feature is the inclusion of the name of the manufacturer or distributor whose trade name or trade mark of the drug being discussed. It contains complete medical and pharmaceutical information of every drug used in medicine.

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