Download or read book Bae V Shalala written by and published by . This book was released on 1994 with total page 46 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Decisions and Reports written by United States. Securities and Exchange Commission and published by . This book was released on 2000 with total page 1344 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Sanctions Regimes of Multilateral Development Banks written by Jelena Madir and published by BRILL. This book was released on 2020-11-30 with total page 280 pages. Available in PDF, EPUB and Kindle. Book excerpt: In Sanctions Regimes of Multilateral Development Banks: What Process is Due, Jelena Madir examines the type of due process rights and the level of transparency that should characterise sanctions regimes of multilateral development banks.
Download or read book Punishing Corporate Crime written by James T. O'Reilly and published by Oxford University Press. This book was released on 2009-09-03 with total page 296 pages. Available in PDF, EPUB and Kindle. Book excerpt: Punishing Corporate Crime: Legal Penalties for Criminal and Regulatory Violations provides a practical discussion of criminal punishment trends directed at the corporate entity. Corporate punishment, for the most part, has traditionally occurred either in the form of a fine or, in the extreme, a heavy sanction that terminates the business. This timely book analyzes the historical and statutory bases of corporate punishment and reviews the latest remedies now employed by the government, including receivership and monitoring, disgorgement of profits, restitution, integrity agreements, and disbarment from regulated fields. Punishing Corporate Crime explores the new and evolving area of corporate criminal punishment that has emerged in the post- Enron era. This book offers key advice in addressing the new and evolving punishments that face corporations, as well as a consideration of preventative programs.
Download or read book SEC Docket written by United States. Securities and Exchange Commission and published by . This book was released on 1997 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book West s Federal Practice Digest 4th written by and published by . This book was released on 2003 with total page 536 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Generic and Innovator Drugs written by Donald O. Beers and published by Wolters Kluwer. This book was released on 2013-05-22 with total page 2154 pages. Available in PDF, EPUB and Kindle. Book excerpt: Completely updated, the new Eighth Edition of Generic and Innovator Drugs: A Guide to FDA Approval Requirements provides indispensable and practical insights into the FDA approval process. Youand’ll find comprehensive coverage of: Abbreviated new drug applications 505(b)(2) new drug applications Delaying approval of competing products FDA approval of biologic drugs No other book can cover the drug approval process as thoroughly, answering important questions like these: What is required to extend the patent of an FDA-approved product? When must a generic manufacturer notify the innovator manufacturer when submitting an ANDA or 505(b)(2) application? When does the FDA delay approvals because of patent claims, and when does it ignore patents? How can one challenge an FDA exclusivity decision? When can a manufacturer safely sell a drug without prior FDA approval? In what circumstances can a generic manufacturer obtain FDA permission to file an ANDA for a variant of an existing drug? When will the FDA waive or reduce prescription drug user fees? How can a company or an individual avoid debarment? What steps are necessary to comply with the FDAand’s Fraud Policy? When and how can a drug company take advantage of FDA accelerated approval procedures? What are the labeling requirements for exporting approved drugs? How have the changes made by the FDA Safety and Innovation Act, including the Prescription Drug User Fee Act, the Generic Drug User Fee Amendments and the Biosimilars User Fee Act, and the Generating Antibiotic Incentives Now Act affected the overall statutory scheme? Generic and Innovator Drugs: A Guide to FDA Approval Requirements, Eighth Edition provides step-by-step guidance of the approval process and expert interpretation of: The Hatch-Waxman Act (Drug Price Competition and Patent Restoration Act) The Medicare Prescription Drug, Improvement, and Modernization Act The Food and Drug Administration Modernization Act The FDA Export Reform and Enhancement Act The Biologics Price Competition and Innovation Act And more! AUTHOR NOTE Donald O. Beersand’ contributions to this publication were completed before he rejoined the Food and Drug Administration. He has had no part in writing and revising this Eighth Edition.
Download or read book Vercillo V Commodity Futures Trading Commission written by and published by . This book was released on 1997 with total page 106 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Tales from the Sausage Factory written by Daniel L. Feldman and published by State University of New York Press. This book was released on 2010-09-01 with total page 395 pages. Available in PDF, EPUB and Kindle. Book excerpt: A former state legislator and a political scientist team up to show how New York's legislature was once the nation's model professional legislature, and how it might recover from its present dysfunction.
Download or read book FDA Consumer written by and published by . This book was released on 1996 with total page 396 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Federal Procurement Ethics written by Terrence M. O'Connor and published by Berrett-Koehler Publishers. This book was released on 2009-11 with total page 346 pages. Available in PDF, EPUB and Kindle. Book excerpt: A Comprehensive and Easy-to-Use Guide to the Federal Procurement Ethics Requirements! Revised to include recent changes in procurement ethics rules, such as the significant additions to the False Claims Act made by Congress in 2009, this book is a complete, all-in-one resource. This plain-English guide focuses on exactly what procurement professionals—both federal officials and contractor employees—need to know to be in compliance with the law and to conduct better business practices. Federal Procurement Ethics: The Complete Legal Guide, Revised Edition, provides comprehensive, easy-to-understand descriptions of all the ethics rules that procurement professionals in both government and the private sector need to follow. Summaries of recent and relevant court cases that illustrate the need for full compliance with procurement regulations are also included.
Download or read book Cox V Commodity Futures Trading Commission written by and published by . This book was released on 1997 with total page 104 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Fighting Corruption in Public Procurement written by Sope Williams-Elegbe and published by Bloomsbury Publishing. This book was released on 2012-11-06 with total page 240 pages. Available in PDF, EPUB and Kindle. Book excerpt: Anti-corruption measures have firmly taken centre stage in the development agenda of international organisations as well as in developed and developing countries. One area in which corruption manifests itself is in public procurement and, as a result, States have adopted various measures to prevent and curb corruption in public procurement. One such mechanism for dealing with procurement corruption is to debar or disqualify corrupt suppliers from bidding for or otherwise obtaining government contracts. This book examines the issues and challenges raised by the debarment or disqualification of corrupt suppliers from public contracts. Implementing a disqualification mechanism in public procurement raises serious practical and conceptual difficulties, which are not always considered by legislative provisions on disqualification. Some of the problems that may arise from the use of disqualifications include determining whether a conviction for corruption ought to be a pre-requisite to disqualification, bearing in mind that corruption thrives in secret, resulting in a dearth of convictions. Another issue is determining how to balance the tension between granting adequate procedural safeguards to a supplier in disqualification proceedings and not delaying the procurement process. A further issue is determining the scope of the disqualification in the sense of determining whether it applies to firms, natural persons, subcontractors, subsidiaries or other persons related to the corrupt firm and whether disqualification will lead to the termination of existing contracts. The book compares and contrasts the legal, practical and institutional approaches to the implementation of the disqualification mechanism in the European Union, the United Kingdom, the United States, the Republic of South Africa and the World Bank.
Download or read book Reports of Cases Argued and Determined in the Superior Court Appellate Division Chancery Division Law Division and in the County Courts of the State of New Jersey written by New Jersey. Superior Court and published by . This book was released on 1995 with total page 748 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Aviation Law Cases Laws and Related Sources written by Paul B. Larsen and published by Martinus Nijhoff Publishers. This book was released on 2012-06-07 with total page 1396 pages. Available in PDF, EPUB and Kindle. Book excerpt: Written in the context of the post-9/11 legal climate, this text introduces all the major areas of aviation, covering such topics as the international air law regime, crimes involving aircraft, international air carriage, litigation management, and governmental immunity from liability.
Download or read book West s Federal Reporter written by and published by . This book was released on 2002 with total page 1606 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Turner V Glickman written by and published by . This book was released on 1999 with total page 100 pages. Available in PDF, EPUB and Kindle. Book excerpt:
