Regulatory Agencies in Transplantation

2016 ◽  
pp. 1-8
Author(s):  
Belinda Paganafanador
Keyword(s):  
Regulatory Agencies

Boilerplate

2012 ◽  
Author(s):  
Margaret Jane Radin
Keyword(s):  
Economic Efficiency ◽  
Analytical Framework ◽  
Daily Basis ◽  
Regulatory Agencies ◽  
Jury Trial ◽  
Comprehensive Treatment ◽  
New Methods ◽  
And Control ◽  
Fine Print

Boilerplate—the fine-print terms and conditions that we become subject to when we click “I agree” online, rent an apartment, or enter an employment contract, for example—pervades all aspects of our modern lives. On a daily basis, most of us accept boilerplate provisions without realizing that should a dispute arise about a purchased good or service, the nonnegotiable boilerplate terms can deprive us of our right to jury trial and relieve providers of responsibility for harm. Boilerplate is the first comprehensive treatment of the problems posed by the increasing use of these terms, demonstrating how their use has degraded traditional notions of consent, agreement, and contract, and sacrificed core rights whose loss threatens the democratic order. This book examines attempts to justify the use of boilerplate provisions by claiming either that recipients freely consent to them or that economic efficiency demands them, and it finds these justifications wanting. It argues that our courts, legislatures, and regulatory agencies have fallen short in their evaluation and oversight of the use of boilerplate clauses. To improve legal evaluation of boilerplate, the book offers a new analytical framework, one that takes into account the nature of the rights affected, the quality of the recipient's consent, and the extent of the use of these terms. It goes on to offer possibilities for new methods of boilerplate evaluation and control, and concludes by discussing positive steps that NGOs, legislators, regulators, courts, and scholars could take to bring about better practices.

Alternativas farmacéuticas: ¿pueden ser intercambiables?

2020 ◽  
Vol 2 (2) ◽  
pp. 38-42
Author(s):  
Miriam del Carmen Carrasco-Portugal ◽  
Francisco Javier Flores-Murrieta
Keyword(s):  
Generic Substitution ◽  
In Vivo Studies ◽  
Regulatory Agencies ◽  
European Medicines Agency ◽  
Reference Formulation ◽  
Active Moiety ◽  
Significant Difference ◽  
Pharmaceutical Form ◽  
Extent Of Absorption

Pharmaceutical alternatives are products with the same active moiety, but different salt, ester or pharmaceutical form. Regulatory agencies have different criteria for this kind of drug. The European Medicines Agency (EMA) accepts the generic substitution using these alternatives, whereas the Food and Drug Administration (FDA) only authorizes generic substitution of pharmaceutical equivalents. The objective of this paper is to describe some relevant aspects that should be considered before deciding on making a generic substitution with pharmaceutical alternatives. It is important to note that a pharmaceutical alternative must show no significant difference in the rate and extent of absorption (bioequivalence) in a well-conducted in vivo study when compared with the reference formulation. Current Mexican regulations state that generic substitution is possible using pharmaceutical alternatives when bioequivalence is demonstrated in in vivo studies conducted under the NOM-177-SSA1-2013 criteria. In conclusion, generic substitution with pharmaceutical alternatives is possible if these products demonstrate in vivo bioequivalence when compared with the reference product.

Islamic Banking Regulations in Light of Basel II

2010 ◽  
Vol 27 (1) ◽  
pp. 74-101 ◽  
Author(s):  
M. Kabir Hassan ◽  
Muhammad Abdul Mannan Chowdhury
Keyword(s):  
Financial Institutions ◽  
Banking Regulation ◽  
Capital Requirements ◽  
Basel Ii ◽  
Capital Adequacy ◽  
Regulatory Agencies ◽  
Islamic Banking ◽  
Islamic Banks ◽  
Minimum Capital ◽  
Regulatory Standards

This paper seeks to determine whether the existing regulatory standards and supervisory framework are adequate to ensure the viability, strength, and continued expansion of Islamic financial institutions. The reemergence of Islamic banking and the attention given to it by regulators around the globe as to the implications of a recently issued Basel II banking regulation makes this article timely. The Basel II framework, which is based on minimum capital requirements, a supervisory review process, and the effective use of market discipline, aligns capital adequacy with banking risks and provides an incentive for financial institutions to enhance risk management and their system of internal controls. Like conventional banks, Islamic banks operate under different regulatory regimes. The still diverse views held by the regulatory agencies of different countries on Islamic banking and finance operations make it harder to assess the overall performance of international Islamic banks. In light of the increased financial innovation and diversity of instruments offered in Islamic finance, the need to improve the transparency of bank operations is particularly relevant for Islamic banks. While product diversity is important in maintaining their competitiveness, it also requires increased transparency and disclosure to improve the understanding of markets and regulatory agencies. The governance of Islamic banks is made even more complex by the need for these banks to meet a set of ethical and financial standards defined by the Shari`ah and the nature of the financial contracts banks use to mobilize deposits. Effective transparency in this area will greatly enhance their credibility and reinforce their depositors and investors’ level of confidence.

Collusion in the Turkish Banking Sector

2012 ◽  
Author(s):  
Resul Aydemir
Keyword(s):  
Banking Sector ◽  
Structural Model ◽  
Banking Industry ◽  
Market Concentration ◽  
Regulatory Agencies ◽  
Sample Period ◽  
Conjectural Variation ◽  
Average Mark ◽  
Market Conduct ◽  
Variation Approach

In this paper, I consider the Turkish Banking Industry, which is dominated by a few large banks. Using a conjectural variation approach, I estimate a structural model to examine the market conduct of the largest banks for the period 1988-2009. Estimation results suggest that the Turkish banks colluded in the loan market during the sample period where the average mark-up is estimated to be in the range of 44% to 86% depending on the empirical specification. This evidence demonstrates a conflict between market concentration and competition in the Turkish banking industry. Thus, regulatory agencies should be cautious against attempts to increase concentration in the banking industry.

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