Analysis and Case Study Review: FDA Warning Letter To Tismor Health and Wellness

2021 ◽  
Vol 27 (4) ◽  
Author(s):  
Orlando Lopez
Keyword(s):  
Health And Wellness ◽  
Warning Letter ◽  
The Us ◽  
Study Review ◽  
Us Fda

This article provides a breakdown of an interesting US FDA Warning Letter. This Warning Letter is an excellent example of the remediation activities required by the US FDA when inefficiencies are found around access authorization. On 5 December 2019, the US FDA issued a Warning Letter (320-20-10) to the Australian firm Tismor Health and Wellness Pty Limited, following an inspection conducted on May 20 to 24, 2019.

scholarly journals Estimated Cancer Risks Associated with Nitrosamine Contamination in Commonly Used Medications

2021 ◽  
Vol 18 (18) ◽  
pp. 9465
Author(s):  
Kate Li ◽  
Karin Ricker ◽  
Feng C. Tsai ◽  
ChingYi J. Hsieh ◽  
Gwendolyn Osborne ◽  
...  
Keyword(s):  
Environmental Protection Agency ◽  
Animal Species ◽  
Protection Agency ◽  
Cancer Risks ◽  
The Us ◽  
Treatment Of Hypertension ◽  
Us Fda

Many nitrosamines are potent carcinogens, with more than 30 listed under California’s Proposition 65. Recently, nitrosamine contamination of commonly used drugs for treatment of hypertension, heartburn, and type 2 diabetes has prompted numerous Food and Drug Administration (FDA) recalls in the US. These contaminants include the carcinogens NDMA (N-nitrosodimethylamine) and NDEA (N-nitrosodiethylamine) and the animal tumorigen NMBA (N-nitroso-N-methyl-4-aminobutyric acid). NMBA and NDEA are metabolically and/or structurally related to NDMA, an N-nitrosomethyl-n-alkylamine (NMA), and 12 other carcinogenic NMAs. These nitrosamines exhibit common genotoxic and tumorigenic activities, with shared target tumor sites amongst chemicals and within a given laboratory animal species. We use the drug valsartan as a case study to estimate the additional cancer risks associated with NDMA and NDEA contamination, based on nitrosamine levels reported by the US FDA, cancer potencies developed by California’s Proposition 65 program and the US Environmental Protection Agency (EPA), and specific exposure scenarios. These estimates suggest that nitrosamine contamination in drugs that are used long-term can increase cancer risks and pose a serious concern to public health.

Regulatory decisions from the US FDA

2001 ◽  
Vol &NA; (1272) ◽  
pp. 22
Author(s):  
&NA;
Keyword(s):  
The Us ◽  
Us Fda ◽  
Regulatory Decisions

Prohibition, Legalization, and Political Consumerism

2018 ◽  
pp. 740-769 ◽  
Author(s):  
Elizabeth A. Bennett
Keyword(s):  
Social Movements ◽  
Legal Status ◽  
Ethical Issues ◽  
Drug Control ◽  
Psychoactive Substance ◽  
Political Consumerism ◽  
Control Laws ◽  
The Past ◽  
The Us

Cannabis (marijuana) is the most commonly consumed, universally produced, and frequently trafficked psychoactive substance prohibited under international drug control laws. Yet, several countries have recently moved toward legalization. In these places, the legal status of cannabis is complex, especially because illegal markets persist. This chapter explores the ways in which a sector’s legal status interacts with political consumerism. The analysis draws on a case study of political consumerism in the US and Canadian cannabis markets over the past two decades as both countries moved toward legalization. It finds that the goals, tactics, and leadership of political consumerism activities changed as the sector’s legal status shifted. Thus prohibition, semilegalization, and new legality may present special challenges to political consumerism, such as silencing producers, confusing consumers, deterring social movements, and discouraging discourse about ethical issues. The chapter concludes that political consumerism and legal status may have deep import for one another.

Did Groupthink or Polythink Derail the 2016 Raqqa Offensive?

2019 ◽  
Author(s):  
Kasey Barr ◽  
Alex Mintz
Keyword(s):  
Decision Making ◽  
Group Dynamics ◽  
Decision Making Process ◽  
Islamic State ◽  
Study Analysis ◽  
Strategic Decisions ◽  
Case Study Analysis ◽  
The Us ◽  
Tactical Decisions

This chapter examines the effect of group dynamics on the 2016 decision within the administration of President Barack Obama to lead the international coalition in a mission to liberate Raqqa, Syria, from the Islamic State. The authors show that whereas the groupthink syndrome characterized the decision-making process of the US-led coalition’s decision to attack Raqqa, it was polythink that characterized the decision-making dynamics both in the US-led coalition and within the inner circle of Obama’s own foreign policy advisors. Through case-study analysis, the authors illustrate that groupthink is more likely in strategic decisions, whereas polythink is more likely in tactical decisions.

scholarly journals Covid-19 Preparedness and Response Capability: A Case Study of the Hanoi Primary Healthcare System

2021 ◽  
Vol 14 ◽  
pp. 117863292110192
Author(s):  
Minh Van Hoang ◽  
Anh Tuan Tran ◽  
Trang Thu Vu ◽  
Tuan Kim Duong
Keyword(s):  
Public Information ◽  
Enabling Factors ◽  
Cross Sectional ◽  
Emergency Operations ◽  
The Us ◽  
Local Stakeholders ◽  
Control And Prevention ◽  
Issue Public ◽  
Analytical Frameworks

This study examined the coronavirus disease 2019 (COVID-19) preparedness and response of the health system (HS) in Hanoi, Vietnam, and identified enabling factors and barriers. This cross-sectional, mixed-methods study was conducted in 4 urban and peri-urban districts that included some wards with COVID-19-positive cases and some without. The US Centers for Disease Control and Prevention (CDC) analytical frameworks were used. Overall, 10% of health facilities (HFs) failed to fully implement COVID-19 risk determination; 8.8% failed to fully implement stronger community partnerships with local stakeholders to support public health (PH) preparedness; 35% and 2.5% incompletely implemented and did not implement evaluation of PH emergency operations, respectively; 10% did not identify communication channels to issue public information, alerts, warnings, and notifications; 25% incompletely implemented identification, development of guidance, and standards for information; 72.5% had good preventive and treatment collaboration; and 10% did not fully implement procedures for laboratory testing and reporting results. Enablers included sufficient infrastructure and equipment, strong leadership, and good cross-public-sector collaboration with police and military forces. Barriers included workforce constraints, overburdened and inconsistent reporting systems, inappropriate financial mechanisms, ambiguous health governance, and lack of private-sector engagement. Nonetheless, the HS preparedness and response were satisfactory, although further coordinated efforts in evaluation, coordination, communication, and volunteering remain necessary.

scholarly journals The Biosimilar Landscape: An Overview of Regulatory Approvals by the EMA and FDA

Pharmaceutics ◽  
2020 ◽  
Vol 13 (1) ◽  
pp. 48
Author(s):  
Ioana Gherghescu ◽  
M. Begoña Delgado-Charro
Keyword(s):  
Drug Administration ◽  
Action Plan ◽  
European Medicines Agency ◽  
Patient Access ◽  
Clinical Evaluations ◽  
The Past ◽  
The Us ◽  
Improve Patient ◽  
The Eu

Biosimilar medicines expand the biotherapeutic market and improve patient access. This work looked into the landscape of the European and US biosimilar products, their regulatory authorization, market availability, and clinical evaluation undergone prior to the regulatory approval. European Medicines Agency (EMEA, currently EMA) and Food and Drug Administration (FDA) repositories were searched to identify all biosimilar medicines approved before December 2019. Adalimumab biosimilars, and particularly their clinical evaluations, were used as a case study. In the past 13 years, the EMA has received 65 marketing authorization applications for biosimilar medicines with 55 approved biosimilars available in the EU market. Since the first biosimilar approval in 2015, the FDA has granted 26 approvals for biosimilars with only 11 being currently on the US market. Five adalimumab biosimilars have been approved in the EU and commercialized as eight different medicines through duplicate marketing authorizations. Whilst three of these are FDA-approved, the first adalimumab biosimilar will not be marketed in the US until 2023 due to Humira’s exclusivity period. The EU biosimilar market has developed faster than its US counterpart, as the latter is probably challenged by a series of patents and exclusivity periods protecting the bio-originator medicines, an issue addressed by the US’s latest ‘Biosimilar Action Plan’.

scholarly journals Global online platforms, COVID-19, and culture: The global pandemic, an accelerator towards which direction?

2021 ◽  
pp. 016344372199453
Author(s):  
Antonios Vlassis
Keyword(s):  
Soft Power ◽  
Asia Pacific ◽  
Policy Framework ◽  
The European Union ◽  
Online Platforms ◽  
Global Pandemic ◽  
Major Development ◽  
The Us ◽  
Media Platform

The article proposes to consider the COVID-19 global pandemic as new major development for cultural industries and policies and to highlight timely and crucial trends due to the lockdown measures. Thus, it attempts to stimulate the scholarship debate regarding the consequences of the pandemic to the action of global online platforms, as well as to policy and economic aspects of cultural sectors. Taking as case study the audio-visual sector, the article explores whether the US global streaming platforms are the winning players of the lockdown measures and emphasizes the multifaceted strategies developed by US-based platforms in order to strengthen their soft power. Focusing on China and the European Union, the article also argues that the overwhelming action of US-based online platforms triggers the potential emergence of media platform regionalization in the context of COVID-19 pandemic. Finally, it highlights the regulatory challenges and how the new empirical trends are expected to shape the current audio-visual policy framework. The analysis focuses on the period between the beginning of global pandemic in Asia-Pacific in January 2020 and the progressive easing of lockdown measures in North America, Europe and Asia-Pacific in July 2020.

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