Timing of Pediatric Drug Approval and Clinical Evidence Submitted to Regulatory Authorities: International Comparison Among Japan, the United States, and the European Union

2020 ◽  
Vol 108 (5) ◽  
pp. 985-994
Author(s):  
Saeko Hirota ◽  
Takuhiro Yamaguchi
Keyword(s):  
United States ◽  
European Union ◽  
International Comparison ◽  
Clinical Evidence ◽  
Drug Approval ◽  
The United States ◽  
The European Union ◽  
Pediatric Drug ◽  
Regulatory Authorities

Global Markets, National Toolkits

2018 ◽  
Author(s):  
Matthew Gravelle ◽  
Stefano Pagliari
Keyword(s):  
United States ◽  
European Union ◽  
The United States ◽  
Global Markets ◽  
The European Union ◽  
Regulatory Oversight ◽  
Land Grab ◽  
Regulatory Authorities ◽  
Otc Derivatives ◽  
Derivatives Markets

A key trend that has characterized implementation of the international agenda to regulate derivatives has been the emergence of a number of disputes over the territorial scope of regulation, as different countries have sought to extend their regulatory oversight over firms and markets that are not legally domiciled in their jurisdiction. What explains the emergence and continuation of these extraterritorial measures in the regulation of global OTC derivatives markets? This chapter addresses this question by exploring the “regulatory land grab” that has characterized the rules introduced in the United States and the European Union to regulate foreign dealers, CCPs, and trading venues. This chapter will argue that the different degrees of extraterritoriality that have emerged in the post-crisis agenda reflect the challenges that regulatory authorities have faced to implement the new prudential agenda in a manner that addresses the highly internationalized nature of derivatives markets.

Assessment of Regulatory Strategies for Orphan Drug Development and Approval Process in USA & EU

2021 ◽  
Vol 12 (4) ◽  
pp. 2492-2500
Author(s):  
Sadiq Basha G ◽  
Srinivasan R
Keyword(s):  
United States ◽  
European Union ◽  
Drug Development ◽  
Rare Disease ◽  
Orphan Drug ◽  
Drug Approval ◽  
The United States ◽  
Pharmaceutical Drugs ◽  
The European Union ◽  
Orphan Drug Act

Orphan medicines are pharmaceutical drugs or vaccines supposed to deal with, preventing or diagnose of a rare disease (viz., ailment, Huntington's disease, syndrome, etc.). The meaning of rare sicknesses varies throughout some jurisdictions, however, generally contemplates the ailment of occurrence, severity, and life of alternate healing options. An uncommon ailment isn't worldwide and depends on the rules and guidelines officially adopted and approved via each region or U.S.A. The Orphan Drug Act, 1983 (ODA) has been recognized and adopted in numerous nations, international (United States of America (USA) and European Union (EU).) in the preceding 35 years, and has effectively advanced R and D ventures to widen new pharmaceuticals for the remedy of rare sickness. The rate of occurrences of such diseases were outpaced at an extra pace than the speed with which medicines are researched and developed to treat rare diseases. One of the main reasons is that the pharmaceutical industry is not interested in researching the enhancement of orphan medicines since they no longer have a significant large market. Despite the multiple incentives provided by the orphan drug act, this is the current reality. However, in this article, we've tried to concentrate on the current regulatory framework, current concepts of rare disease, regulatory challenges for rare disease drug development, and orphan drug approval in the United States & the European Union.

Russian Federation and the United States of America: geostrategic directions to manage the Ukrainian crisis

2019 ◽  
pp. 123
Author(s):  
Attarid Awadh Abdulhameed
Keyword(s):  
United States ◽  
European Union ◽  
National Security ◽  
Russian Federation ◽  
United States Of America ◽  
The United States ◽  
The European Union ◽  
The Usa ◽  
Ukrainian Crisis ◽  
Zero Sum

Ukrainia Remains of huge importance to Russian Strategy because of its Strategic importance. For being a privileged Postion in new Eurasia, without its existence there would be no logical resons for eastward Expansion by European Powers.  As well as in Connection with the progress of Ukrainian is no less important for the USA (VSD, NDI, CIA, or pentagon) and the European Union with all organs, and this is announced by John Kerry. There has always ben Russian Fear and Fear of any move by NATO or USA in the area that it poses a threat to  Russians national Security and its independent role and in funence  on its forces especially the Navy Forces. There for, the Crisis manyement was not Zero sum game, there are gains and offset losses, but Russia does not accept this and want a Zero Sun game because the USA. And European exteance is a Foot hold in Regin Which Russian sees as a threat to its national security and want to monopolize control in the strategic Qirim.

COMPARATIVE ANALYSIS OF THE CURRENT FRENCH FOREIGN POLICY ACTIVITY

2019 ◽  
Vol 22 (2) ◽  
pp. 74-79
Author(s):  
Nargiza Sodikova ◽  
◽  
◽  
Keyword(s):  
United States ◽  
European Union ◽  
Foreign Policy ◽  
International Security ◽  
The United States ◽  
Foreign Affairs ◽  
Modern Time ◽  
The European Union ◽  
National Interests ◽  
French Foreign Policy

Important aspects of French foreign policy and national interests in the modern time,France's position in international security and the specifics of foreign affairs with the United States and the European Union are revealed in this article

Ocena antykryzysowej polityki gospodarczej Stanów Zjednoczonych i wybranych państw członkowskich Unii Europejskiej w latach 2005–2014

2016 ◽  
pp. 26-46
Author(s):  
Marcin Jan Flotyński
Keyword(s):  
United States ◽  
European Union ◽  
Financial Markets ◽  
Global Economy ◽  
Global Financial Crisis ◽  
The United States ◽  
The European Union ◽  
High Volatility ◽  
The Global Financial Crisis ◽  
Domestic Products

The global financial crisis in 2007–2009 began a period of high volatility on the financial markets. Specifically, it caused an increased amplitude of fluctuations of the level of gross domestic products, the level of investment and consumption and exchange rates in particular countries. To address the adverse market circumstances, governments and central banks took actions in order to bolster the weakening global economy. The aim of this article is to present the anti-crisis actions in the United States and selected member states of the European Union, including Poland, and an assessment of their efficiency. The analysis conducted indicates that generally the actions taken in the United States in response to the crisis were faster and more adequate to the existing circumstances than in the European Union.

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