Meeting report: an exploration into the scientific and regulatory aspects of pharmaceutical drug quality in the United States

Author(s):  
Bridget M. Flavin ◽  
Laura E. Happe ◽  
Randy C. Hatton
2020 ◽  
Vol 14 (3) ◽  
pp. 679-686
Author(s):  
Julia Han ◽  
Lutz Heinemann ◽  
Barry H. Ginsberg ◽  
Shridhara Alva ◽  
Matthias Appel ◽  
...  

This is a summary report of the most important aspects discussed during the YSI 2300 Analyzer Replacement Meeting. The aim is to provide the interested reader with an overview of the complex topic and propose solutions for the current issue. This solution should not only be adequate for the United States or Europe markets but also for all other countries. The meeting addendum presents three outcomes of the meeting.


2020 ◽  
Vol 29 (3) ◽  
pp. 476-490
Author(s):  
Vinaya Manchaiah ◽  
George Vlaescu ◽  
Srinivas Varadaraj ◽  
Elizabeth Parks Aronson ◽  
Marc A. Fagelson ◽  
...  

Objective Although tinnitus is one of the most commonly reported symptoms in the general population, patients with bothersome tinnitus are challenged by issues related to accessibility of care and intervention options that lack strong evidence to support their use. Therefore, creative ways of delivering evidence-based interventions are necessary. Internet-based cognitive behavioral therapy (ICBT) demonstrates potential as a means of delivering this support but is not currently available in the United States. This article discusses the adaptation of an ICBT intervention, originally used in Sweden, Germany, and the United Kingdom, for delivery in the United States. The aim of this study was to (a) modify the web platform's features to suit a U.S. population, (b) adapt its functionality to comply with regulatory aspects, and (c) evaluate the credibility and acceptability of the ICBT intervention from the perspective of health care professionals and patients with bothersome tinnitus. Materials/Method Initially, the iTerapi ePlatform developed in Sweden was adopted for use in the United States. Functional adaptations followed to ensure that the platform's functional and security features complied with both institutional and governmental regulations and that it was suitable for a U.S. population. Following these adaptations, credibility and acceptance of the materials were evaluated by both health care professionals ( n = 11) and patients with bothersome tinnitus ( n = 8). Results Software safety and compliance regulatory assessments were met. Health care professionals and patients reported favorable acceptance and satisfaction ratings regarding the content, suitability, presentation, usability, and exercises provided in the ICBT platform. Modifications to the features and functionality of the platform were made according to user feedback. Conclusions Ensuring that the ePlatform employed the appropriate features and functionalities for the intended population was essential to developing the Internet-based interventions. The favorable user evaluations indicated that the intervention materials were appropriate for the tinnitus population in the United States.


2016 ◽  
Vol 11 (3) ◽  
pp. 45-57
Author(s):  
Jo M Martins

The purpose of health systems is the pursuit of healthy lives. The performance of the Australian health system over the last decade is compared with the United Kingdom and its three other offshoots: the United States, Canada and New Zealand. In the first instance, system performance is assessed in terms of threats to healthy lives from risk factors and changes that have taken place during the decade. In view of the emphasis of the five systems on the return to health after trauma and illness, and the human-resource intensity of health services, an appraisal is made of changes in the number of the major health professionals in relation to the growing populations. Then related changes in hospital, medical practitioner and dentist services are assessed. Changes in pharmaceutical drug prescriptions in Australian are also examined. The levels of national expenditures arising from the provision health services are then considered in the context of the costs of administration of the varied organisational modes, use of expensive medical technologies, pharmaceutical drug consumption and remuneration of health professionals. Finally, health outcomes in Australia and the other four countries are assessed in accordance with their human development level, life expectancy, potential years of life lost from different causes, as well as healthy life expectancies. Further, gaps in health and life expectancy of Indigenous people in the United States, Canada, New Zealand and Australia are reviewed, as well as health and survival inequalities among people in different social strata in each country. Abbreviations: GDP – Gross Domestic Product; HDI – Human Development Index.


2014 ◽  
Vol 9 (1) ◽  
Author(s):  
Kevin McCluskey ◽  
Scott Bates ◽  
Kyria Boundy-Mills ◽  
Arianna Broggiato ◽  
Anthony Cova ◽  
...  

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