scholarly journals Regulatory challenges of convalescent plasma collection during the evolving stages of COVID‐19 pandemic in the US

Transfusion ◽  
2021 ◽  
Author(s):  
Sajjad Hassan ◽  
Kamille A. West ◽  
Kathleen Conry‐Cantilena ◽  
Valeria De Giorgi
Author(s):  
Patel Drashti ◽  
Charmy S Kothari ◽  
Singh Shantanu ◽  
Shah Manan

The medical device market is generally seen as an area with high growth potential and provides greater profit margins including significant positive benefits to the patients. As the medical device regulations and the guidance document are becoming stringent in the US, manufacturers of these types of products are now facing these conundrums along with a need for clarification on matters related to various drug and device provisions. The European Union is making major changes to the Medical Device Directive which is its regulatory scheme for devices. Some parts are focused on the medical devices. The new changes in the regulations represent an important step forward in the growing philosophy of medical devices in Europe. Along with the regulatory challenges, there are various challenges faced during the innovation of such products. There are many factors that affect innovation including the patent aspects. In general, the key thing is that small firm face lots of difficulty compared to larger firm in bringing medical device in market. Thus, the proposed manuscript focuses on understanding the regulatory issues in various countries for ease of innovation and marketing authorization of medical devices.


Author(s):  
Silvio Goglio ◽  
Panu Kalmi

The national cases of co-operative banking will be considered by pattern: credit unions (as in the UK and the US), decentralized networks (as in Germany, Italy, and Austria), and centralized networks (as in France, the Netherlands, and Finland). The analysis will consider the historical evolution that has characterized the different patterns with regard to national peculiarities (social and economic). We also discuss performance measurement in financial co-operatives and how the recent economic and financial crises have impacted their success vis-à-vis shareholder banks. We also consider corporate governance and regulatory challenges facing financial co-operatives. The present process of hybridization in the sector will also be taken into consideration as well as relaunched co-operatives in the twenty-first century.


2021 ◽  
Vol 1 (12) ◽  
Author(s):  
Sirjana Pant ◽  
Rupinder Bagha ◽  
Sarah McGill

Plasma is used by pharmaceutical companies to make plasma-derived medicinal products (PDMPs). PDMPs are used to treat conditions such as immune deficiencies and bleeding disorders. Several PDMPS are included in the WHO Model Lists of Essential Medicines. According to the WHO, self-sufficiency driven by voluntary (non-remunerated) plasma donations is an important national goal to ensure an adequate supply is secured to meet the needs of the population. Australia, New Zealand, the UK, the Netherlands, and France only allow public or not-for-profit sectors to collect plasma for fractionation. Each of the 5 countries have toll or contract agreements with 1 private commercial plasma fractionator to manufacture PDMPs from the plasma collected within their respective countries. None of these countries pay plasma donors. Donors are only permitted to donate every 2 weeks (24 to 26 times per year) in these 5 countries. Austria, the Czech Republic, Germany, and the US allow both public and non-for-profit sectors, as well as commercial private plasma collection centres, to operate in the country. Private, not-for-profit, or public plasma collection centres in these 4 countries offer monetary compensation and other in-kind incentives to plasma donors. While the Czech Republic limits plasma donation to every 2 weeks, a much higher frequency of donation is allowed in other countries; up to 50 times per year in Austria, 60 times per year in Germany, and more than 100 times per year in the US. Austria, the Czech Republic, Germany, and the US (which allow commercial private plasma collectors to operate and pay donors) are 100% self-sufficient in immunoglobulins. These 4 countries collect the most plasma, which is from paid donors. In 2017, Austria, the Czech Republic, Germany, and the US collected 75 litres per 1,000 people, 45 litres per 1,000 people, 36 litres per 1,000 people, and 113 litres per 1,000 people of plasma for fractionation, respectively. Countries that do not pay donors including Australia, New Zealand, the UK, the Netherlands, and France are dependent to some extent on US and European Union donors who are paid for the supply of plasma or imported PDMPs. The limited literature search conducted for the Environmental Scan did not identify publications on events of disease transmission through PDMPs manufactured from either paid or non-renumerated donors’ plasma, the impact of plasma collection centres (including those that do or do not pay donors) on the collection of whole blood or other blood components, or the long-term costs associated with plasma self-sufficiency on the health care system.


Author(s):  
Ventoruzzo Marco

This chapter turns to the controversial issue of insider dealing. It offers a general background for the analytical discussion of the single provisions of the Market Abuse Regulation, before taking a broad view at the evolution of the phenomenon and the legal discourse surrounding it. To that end, this chapter adopts an historical perspective, and compares and contrasts different regulatory approaches (in the US and Europe, which offer a good template for most existing regulatory models). The economic and ethical basis invoked to support—or criticize—the prohibition of insider trading is then discussed. Finally, this chapter also discusses a few open questions or regulatory challenges that might be relevant in the next few years.


2018 ◽  
Vol 13 (12) ◽  
pp. 1924-1932 ◽  
Author(s):  
Douglas M. Silverstein ◽  
Scott O. Trerotola ◽  
Timothy Clark ◽  
Garth James ◽  
Wing Ng ◽  
...  

Central venous catheters remain a vital option for access for patients receiving maintenance hemodialysis. There are many important and evolving clinical and regulatory considerations for all stakeholders for these devices. Innovation and transparent and comprehensive regulatory review of these devices is essential to stimulate innovation to help promote better outcomes for patients receiving maintenance hemodialysis. A workgroup that included representatives from academia, industry, and the US Food and Drug Administration was convened to identify the major design considerations and clinical and regulatory challenges of central venous catheters for hemodialysis. Our intent is to foster improved understanding of these devices and provide the foundation for strategies to foster innovation of these devices.


2021 ◽  
pp. 1-10
Author(s):  
Machiko Kanetake

Abstract Dual-use export control regulates the trade of items which serve both civilian and military purposes. Justification for imposing export controls has been furnished by the need for safeguarding regional and international security, especially the non-proliferation of weapons of mass destruction. The rationale for applying export controls has been subject to challenges, however. This Security and Human Rights special issue addresses the underlying justification for imposing export controls by focusing on their technological fronts. Scott A. Jones’ piece sheds light on the regulatory challenges that have arisen for the US’ control over so-called “emerging” technologies. Cindy Whang moves on to compare the US’ approach with that of the EU’s dual-use export control. Ben Wagner proposes a set of policy options for the design of export controls on digital technologies, so that they can serve as an effective vehicle for promoting the protection of human rights.


2004 ◽  
Vol 32 (1) ◽  
pp. 181-184
Author(s):  
Amy Garrigues

On September 15, 2003, the US. Court of Appeals for the Eleventh Circuit held that agreements between pharmaceutical and generic companies not to compete are not per se unlawful if these agreements do not expand the existing exclusionary right of a patent. The Valley DrugCo.v.Geneva Pharmaceuticals decision emphasizes that the nature of a patent gives the patent holder exclusive rights, and if an agreement merely confirms that exclusivity, then it is not per se unlawful. With this holding, the appeals court reversed the decision of the trial court, which held that agreements under which competitors are paid to stay out of the market are per se violations of the antitrust laws. An examination of the Valley Drugtrial and appeals court decisions sheds light on the two sides of an emerging legal debate concerning the validity of pay-not-to-compete agreements, and more broadly, on the appropriate balance between the seemingly competing interests of patent and antitrust laws.


2000 ◽  
Vol 16 (2) ◽  
pp. 107-114 ◽  
Author(s):  
Louis M. Hsu ◽  
Judy Hayman ◽  
Judith Koch ◽  
Debbie Mandell

Summary: In the United States' normative population for the WAIS-R, differences (Ds) between persons' verbal and performance IQs (VIQs and PIQs) tend to increase with an increase in full scale IQs (FSIQs). This suggests that norm-referenced interpretations of Ds should take FSIQs into account. Two new graphs are presented to facilitate this type of interpretation. One of these graphs estimates the mean of absolute values of D (called typical D) at each FSIQ level of the US normative population. The other graph estimates the absolute value of D that is exceeded only 5% of the time (called abnormal D) at each FSIQ level of this population. A graph for the identification of conventional “statistically significant Ds” (also called “reliable Ds”) is also presented. A reliable D is defined in the context of classical true score theory as an absolute D that is unlikely (p < .05) to be exceeded by a person whose true VIQ and PIQ are equal. As conventionally defined reliable Ds do not depend on the FSIQ. The graphs of typical and abnormal Ds are based on quadratic models of the relation of sizes of Ds to FSIQs. These models are generalizations of models described in Hsu (1996) . The new graphical method of identifying Abnormal Ds is compared to the conventional Payne-Jones method of identifying these Ds. Implications of the three juxtaposed graphs for the interpretation of VIQ-PIQ differences are discussed.


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