Review of form 483s and warning letters to pharmaceutical manufacturers issued by USFDA

2021 ◽  
pp. 174113432110235
Author(s):  
Chandan Saini ◽  
Ashish Miglani ◽  
Pankaj Musyuni ◽  
Geeta Aggarwal
Keyword(s):  
Public Health ◽  
United States ◽  
Regulatory Authority ◽  
The United States ◽  
Federal Law ◽  
Pharmaceutical Manufacturers ◽  
The World ◽  
Considerable Impact ◽  
A Company ◽  
Responsible Person

Regular inspections are carried out to ensure system conformity by the Food and Drugs Regulatory Authority (FDA) of the United States one of the most stringent regulatory authorities in the world. The inspectors send Form 483 to the management after the inspection, detailing the inappropriate conditions. Because the FDA guidelines are difficult to comply with, a company can contravene the regulations. If any significant infringements can affect the protection, quality, effectiveness, or public health of the drug is identified, the FDA issues advice to the company. Warning Letters (WL) shall be an official notification of non-compliance with federal law within a period to be issued by manufacturer, clinician, distributor, or responsible person in the company. The delivery of a letter has a considerable impact on the company's reputation and position in the market. Inadequate WL reactions could lead to a refusal, import denial, memorandum or even conviction and order. A brief study was conducted in this document of Form 483 and WL for four years (2017–2020) on an understanding the regulatory provisions.

scholarly journals Challenges in evaluating the use of viral sequence data to identify HIV transmission networks for public health

2020 ◽  
Vol 12 (s1) ◽  
Author(s):  
Rami Kantor ◽  
John P. Fulton ◽  
Jon Steingrimsson ◽  
Vladimir Novitsky ◽  
Mark Howison ◽  
...  
Keyword(s):  
Public Health ◽  
United States ◽  
Hiv Transmission ◽  
Sequence Data ◽  
The United States ◽  
Viral Sequence ◽  
Transmission Networks ◽  
New Methods ◽  
Hiv Epidemic ◽  
The World

AbstractGreat efforts are devoted to end the HIV epidemic as it continues to have profound public health consequences in the United States and throughout the world, and new interventions and strategies are continuously needed. The use of HIV sequence data to infer transmission networks holds much promise to direct public heath interventions where they are most needed. As these new methods are being implemented, evaluating their benefits is essential. In this paper, we recognize challenges associated with such evaluation, and make the case that overcoming these challenges is key to the use of HIV sequence data in routine public health actions to disrupt HIV transmission networks.

scholarly journals Do Callable Convertibles Support The Investment Process Of A Company? An Analysis Of The World Market Of Hybrid Debt

2017 ◽  
Vol 20 (2) ◽  
pp. 5-19
Author(s):  
Damian Kaźmierczak
Keyword(s):  
United States ◽  
The United States ◽  
World Market ◽  
Convertible Bonds ◽  
Investment Projects ◽  
Service Companies ◽  
The World ◽  
Investment Process ◽  
A Company

Using a sample of 1,705 convertible bonds issued by manufacturing and service companies from the United States (1,138 issues); Europe (270); and Asia (297) between 2004 and 2014 this paper investigates the role of callable convertibles in the corporate investment process. This research shows first that callable convertibles are used to finance investment projects particularly by American firms which may exercise new investment options to improve poor financial performance. Secondly, the same strategy may be followed by European companies, but they seem not to carry out investments on as large a scale as American firms. Thirdly, the research results do not provide evidence that Asian enterprises use callable convertibles for investment purposes: they likely use these instruments for different reasons.

scholarly journals Green Medicine: Using Lessons From Tort Law and Environmental Law to Hold Pharmaceutical Manufacturers and Authorized Distributors Liable for Injuries Caused by Counterfeit Drugs

2007 ◽  
Vol 69 (2) ◽  
Author(s):  
Stephanie Feldman Aleong
Keyword(s):  
United States ◽  
Prescription Drugs ◽  
Environmental Law ◽  
Tort Law ◽  
The United States ◽  
World Health ◽  
Counterfeit Drugs ◽  
Pharmaceutical Manufacturers ◽  
The World ◽  
Health Organization

The majority of the American public would be astonished by the frequency with which counterfeit prescription drugs appear on reputable drug store shelves. In 2004, the Food and Drug Administration (FDA) noted that those who counterfeit prescription drugs “deny ill patients the therapies that can alleviate suffering and save lives.” In 2006, the World Health Organization (WHO) estimated that there exists a $30 billion market in fake drugs. Although the FDA has tried to characterize the incidence of counterfeit medications in the United States prescription drug marketplace as “rare,” numerous instances of counterfeit drugs reaching consumers from the shelves of large, retail pharmacy chains have been well-documented. As a result, the FDA has lifted the stay on a nearly fifteen-year-old regulation that requires distributors of prescription drugs to document the sources of the drugs they peddle. In fact, the high risk of receiving fake or diverted drugs in the United States has been referred to as “pharmaceutical roulette” for millions of American patients.

scholarly journals Coronavirus and Pharmacists

2020 ◽  
Vol 67 (1) ◽  
pp. 6-6
Author(s):  
Ken Thai
Keyword(s):  
Public Health ◽  
United States ◽  
The United States ◽  
Public Health Emergency ◽  
World Health ◽  
The Novel ◽  
Wuhan City ◽  
The World ◽  
High Season ◽  
Health Organization

Pharmacists and our fellow healthcare colleagues typically expect a break from our “high season” of cough, cold, and flu patients that have filled our pharmacies, clinics, and hospitals by this time of the year. Everyone is prepping for the end of the winter and the dawning of spring. This year was unlike many as we have heard loud cries across the globe regarding the outbreak of the novel “new” coronavirus. The virus was first detected from the Wuhan City of China. It has since infected tens of thousands of people in China and across the world. In fact, the World Health Organization has declared the outbreak a “public health emergency of international concern.” Health and Human Services Secretary Alex Azar declared a public health emergency for the United States to aid the nation's healthcare community in responding. A proclamation was signed on January 31, 2020, by the United States to suspend entry of anyone who poses a risk of transmitting the coronavirus.

scholarly journals Global Pandemic Trends of COVID-19 in 2020

2021 ◽  
Author(s):  
Hai-Zhen Chen ◽  
Bo Cai ◽  
Jian-Guo Chen
Keyword(s):  
Public Health ◽  
United States ◽  
Mortality Rate ◽  
Incidence Rate ◽  
Case Fatality Rate ◽  
Case Fatality ◽  
The United States ◽  
Cumulative Number ◽  
Fatality Rate ◽  
The World

Abstract Background: The novel coronavirus pneumonia (COVID-19) has been global threaten to public health. This paper provides perspective to the decision-making for public health control of the pandemic or the spread of epidemic.Methods: According to the WHO global reported database, we developed and used the number of cumulative cases, and the number of cumulative deaths to calculate and analyze rates of incidence, mortality, and fatality by country, with respect to the 30 highest outbreak (Top 30) countries.Results： As of December 31, 2020, of the global population of 7.585 billion, the cumulative number of reported cases was 81,475,053, and the cumulative number of deaths was 1,798,050. The incidence rate of COVID-19 was 1074.13 per 100,000 population, the mortality rate was 23.70 per 100,000, and the case fatality rate was 2.21%. Among the Top 30 countries, the five countries with the highest number of reported cumulative cases were, in rank, the United States (19,346,790 cases), India (10,266,674), Brazil (7,563,551), Russia (3,159,297) and France (2,556,708), and the five countries with the highest number of cumulative deaths were the United States (335,789 cases), Brazil (192,681), India (148,738), Mexico (123,845) and Italy (73,604). Globally, the countries with the highest incidence rate were, in rank, Andorra, Luxembourg, Montenegro, San Marino, and Czechia; the countries with the highest mortality rate were, in rank, San Marino, Belgium, Slovenia, Italy, and North Macedonia. The highest fatality rate was found in Yemen, Mexico, Montserrat, Isle of Man, and Ecuador, respectively. In China, 96,673 cases of COVID-19 and 4788 deaths were reported in 2020, ranking the 78th and the 43rd, respectively, in the world. The incidence rate and mortality rate were 6.90/105 and 0.34/105, respectively, ranking 207th and 188th in the world. The case fatality rate was 4.95%, ranking 11th in the world.Conclusions： The COVID-19 prevalence is still on the rise, and the turning points of incidence and mortality are not yet forecasted. Personal protection, anti-epidemic measures and efforts from public health personnel, medical professionals, biotechnology R&D personnel, effectiveness of the vaccination programs and the governments, are the important factors to determine the future prevalence of this coronavirus disease.

scholarly journals Covid-19: The Burden of a Pandemic and Effectiveness of Face Masks in Curtailing Its Spread

2021 ◽  
Vol 7 (1) ◽  
pp. 1-4
Author(s):  
Muyiwa Seun OLUWAFEMI ◽  
◽  
Ese Freeman OGHAGHARE ◽  
Ese Freeman OGHAGHARE ◽  
Bassey UDOFIA ◽  
...  
Keyword(s):  
Public Health ◽  
United States ◽  
Health System ◽  
World Economy ◽  
Face Mask ◽  
The United States ◽  
Public Places ◽  
The World ◽  
The Government

The outbreak of Covid-19 presents an unprecedented threat to public health with a devastating effect on the world economy and health system. In March 2020, the government of the United States responded by adopting the use of face masks as one of the measures to prevent the spread of coronavirus in public places. The increase in the spread of coronavirus necessitated the need for researchers to evaluate the effectiveness of face masks as a measure to control the spread of coronavirus. It became of more concern when alternatives to face masks were observed in public places. This article reviewed factors that affect the effectiveness of face masks and the choice of an effective face mask as reported by several studies. The use of appropriate face masks and other measures to prevent the spread of coronavirus should be encouraged at all levels. Keywords: COVID-19, SARS-CoV-2, FACE-MASKS.

scholarly journals Collegiate Athletes' Concussion Awareness, Understanding, and -Reporting Behaviors in Different Countries With Varying Concussion Publicity

2020 ◽  
Author(s):  
Erica Beidler ◽  
Jessica Wallace ◽  
Alia A. Alghwiri ◽  
Siobhan O'Connor
Keyword(s):  
Public Health ◽  
United States ◽  
Sports Medicine ◽  
Collegiate Athletes ◽  
The United States ◽  
Self Report ◽  
Health Concern ◽  
Reporting Behaviors ◽  
The World ◽  
History Of

Context Concussions are a global public health concern, and education on the importance of self-reporting may not reach all athletes to the same degree around the world. Objective To determine if differences were present in the concussion awareness, understanding, and -reporting behaviors of collegiate athletes' in 3 countries with varied degrees of concussion publicity. Design Cross-sectional survey. Setting Collegiate sports medicine clinics. Patients or Other Participants Collegiate athletes in the United States (n = 964; high publicity), Ireland (n = 302; moderate publicity), and Jordan (n = 129; low publicity). The degree of concussion publicity was categorized based on the extent of national public health awareness initiatives, care guidelines, research publications, and mass media coverage. Main Outcome Measure(s) Participants completed a 10- to 15-minute survey on concussion awareness, understanding, and -reporting behaviors. The main outcome measures were concussion education (awareness; 21 options; select all sources of concussion information), concussion knowledge (understanding; maximum score of 49), and diagnosed/nondisclosed concussion history (reporting behaviors; self-report yes/no items). Results A higher proportion of Jordanian athletes reported never having received concussion information previously (73.6%) than Irish (24.2%) or US athletes (9.4%). Knowledge differed among countries (P < .0001, η2 = .28), with US athletes displaying higher total knowledge scores (40.9 ± 4.5) than Jordanian (35.1 ± 5.6) and Irish (32.1 ± 3.5) athletes. A greater percentage of Irish and US athletes reported a history of a diagnosed concussion (31.8% and 29.6%, respectively) and history of concussion nondisclosure (25.2% and 15.5%, respectively) than Jordanian athletes (2.3% and 0.0% for history of a diagnosed concussion and history of concussion nondisclosure, respectively). Conclusions In the United States, where concussion publicity is high, formal legislation exists, and sports medicine resources, concussion awareness and understanding were increased. More culturally appropriate concussion initiatives are needed globally to ensure that athletes around the world can identify concussive injuries and understand the dangers of continued sport participation while concussed.

Mass Incarceration in the United States: From Punishment to Public Health

2019 ◽  
Author(s):  
Ernest Drucker
Keyword(s):  
Public Health ◽  
United States ◽  
Social Stigma ◽  
Mass Incarceration ◽  
The United States ◽  
Community Supervision ◽  
Recidivism Rate ◽  
Mass Imprisonment ◽  
The World ◽  
The Right

Mass imprisonment in the United States is an epidemic that has spread across five generations affecting millions of individuals, their families, and hundreds of communities. The United States imprisons more people than any other nation in the world—with over 2 million behind bars and another 5 to 7 million under community supervision on parole and probation. With 5% of the world’s population, the United States has 25% of all the world’s prisoners. This U.S. system imposes many punitive policies, holding more of its citizens in isolation and solitary confinement than all the other prisons of the world combined and imposing the highest rates of life sentences of any nation. This public health analysis of mass incarceration in the United States (first proposed in Ernest Drucker’s 2011 book, A Plague of Prisons: The Epidemiology of Mass Incarceration in America) must therefore also address the high rates of prisoner reentry that accompany it—with over 600,000 U.S. prisoners reentering society each year—with the highest recidivism rate of any nation. This population is disproportionally poor and members of America’s large minority populations (African Americans and Latinos). The public health model provides a new tool for ending the American epidemic of mass imprisonment and, of equal importance, healing those who have survived its blows. This stage of the American story of mass incarceration is covered in Drucker’s 2018 book, Decarcerating America: From Mass Punishment to Public Health. But releasing people from prisons is not enough—the taint of punishment has a long-lasting and debilitating effect on the millions who return from prison to their home communities—facing social stigma and the many restrictions placed upon them as part of the conditions of parole—including limits of their access to public education, healthcare, and housing—as well as convicted felons’ loss of the right to vote. The United States badly needs a paradigm shift that replaces these impediments to successful reentry after prison, creating instead a positive place and normal life for this population in the outside world.

The Lingua Franca of Human Rights and the Rise of a Global Bioethic

2001 ◽  
Vol 10 (3) ◽  
pp. 253-263 ◽  
Author(s):  
LORI P. KNOWLES
Keyword(s):  
Public Health ◽  
United States ◽  
Financial Markets ◽  
Global Economy ◽  
The United States ◽  
Global Capitalism ◽  
Healthcare It ◽  
Cultural Exchanges ◽  
The World ◽  
Environmental Development

Globalization is often discussed as if it were a recent phenomenon relating primarily to the development of world financial markets and improvements in information and travel technologies. But globalization is an ancient process, beginning with mercantile and cultural exchanges and facilitated by advances in transportation. In the twentieth century, the results of globalization can be seen in the rise of global capitalism and in the construction of a global economy. Most recently, the process of globalization has moved beyond the world of finance, however, into areas still traditionally thought of as national concerns, such as culture and healthcare. It is no surprise, therefore, that increasingly the challenges the United States is confronting in healthcare, biotechnology, and the environment are simultaneously faced by the international community as a whole. In the wake of the HIV pandemic, growing environmental consciousness, and a series of sensational advances in biotechnology, there is a dawning realization that problems such as improving public health, regulating advances in biotechnology, and achieving sustainable environmental development transcend national borders. In other words, bioethics concerns are global in nature.

scholarly journals 6.A. Round table: Protecting borders and preparing for a pandemic: responses around the world to COVID19

2020 ◽  
Vol 30 (Supplement_5) ◽  
Author(s):  
◽  
Keyword(s):  
Public Health ◽  
United States ◽  
Health Care ◽  
Global Health ◽  
Health Systems ◽  
Round Table ◽  
The United States ◽  
The World ◽  
Public Health Officials ◽  
Novel Coronavirus

Abstract COVID19 challenges every dimension of public health systems, from research and health care treatment to public communication, coercive mechanisms such as quarantine, and respect for individual rights. This round table has 3 key objectives: To understand patterns in responses across countries, and in particular the different ways that authoritarian and democratic regimes responded;To identify comparative lessons for understanding the European experience from other high-income health systems;To draw conclusions about the politics of effective public health intervention and likely lessons of COVID19. Burris will present on how although initial control efforts took the form of travel restrictions, quarantine and isolation, sustained human-to-human community transmission of COVID-19 in the United States pushed authorities to move from these traditional tools to the challenge of promoting social distancing behavior and managing a surge in demand for health care. These challenges posed new and urgent questions of practical regulation and distributive justice as underlying social disparities created differing levels of vulnerability. This presentation reviews the first six months of the response in the US from a legal and social justice standpoint, focusing on issues of equity. Fafard will analyze the communications role of senior public health officials during the COVID-19 outbreak in five countries; their public messaging across a range of media platforms, including how they deal with misinformation; and the extent to which members of the public receive, understand, and trust this messaging. Kavanagh will discuss how relative democratic and autocratic political institutions have influenced early responses to the novel coronavirus outbreak. Using evidence from process tracing in China, Iran, the United States, South Korea, and Italy, this presentation evaluates the hypothesis advanced or implied by many global public health officials that authoritarian governments have an advantage in disease response Peralta will discuss how severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) epidemic highlighted the heterogeneity in the measured used for containment and mitigation by governments. Where authoritarian states, that theoretically have more policy options for containment and mitigation, have an advantage in an epidemic event remains unclear. This presentation will compare measures taken by governments and health authorities in five selected authoritarian states and five democracies and evaluate the capacity of epidemic containment. Willison will highlight how political elites in the United States define public health threats; how partisanship and party competition define public health responses, including expenditure and coordination; and how party and media elites draw on established tensions in American politics to frame outbreaks in ways advantageous to the parties. Key messages We will focus on similarities and differences in responses to COVID-19 around the world, highlight effective measures, and reflect on lessons learned in the first few months of this novel coronavirus. We will draw attention to issues of human rights and health equity among government responses. Panelists: Scott Burris Temple University, Philadelphia, USA Contact: [email protected] Patrick Fafard University of Ottawa, Ottawa, Canada Contact: [email protected] Matthew Kavanaugh Global Health Policy & Governance Initiative at the O'Neill Institute for National and Global Health, Washington DC, USA Contact: [email protected] André Peralta-Santos University of Washington, Seattle, USA Contact: [email protected] Charley Willison University of Washington, Seattle, USA Contact: [email protected]

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